Quality System Resume Samples

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J Sipes

Jeromy

Sipes

50566 Thiel Spring

Boston

+1 (555) 536 9661

50566 Thiel Spring

Boston

Phone

p +1 (555) 536 9661

Experience Experience

New York, NY

Quality System Coordinator

New York, NY

Smith, Prosacco and Johnston

New York, NY

Quality System Coordinator

Responsible for providing Quality Manager and department management team with audit results and lead in closing out corrective action issues
Perform other duties as assigned by the Quality Manager
Actively influences the team and other fellow workers and seen as role model for Collaboration and Teamwork
Develop and maintain Management Reports related to Mafact / KMI (Key Measurement Indicator) like regular Scrap Reduction and Downtime Reports
Analyze, manage and facilitate customer complaint , internal and supplier non-conformance data to drive to product / manufacturing improvements
Coordinate data collection and perform analysis for quality metrics, quality improvement initiatives, CAPAs, NCs, or Quality Systems
Develops and implements quality procedures for each process, adhering to the industry guidelines

Los Angeles, CA

Quality System Manager

Los Angeles, CA

Kozey Group

Los Angeles, CA

Quality System Manager

Work with cross functional technical teams to influence to develop quality system and ensure compliance of new product introduction with local regulations
Compile & write training material and conduct training sessions on Quality System improvement tools & methodologies
Partner with R&D and QC team to ensure high quality products are transitioned effectively from development to the market
Identify opportunities for continuous improvement of the Quality Systems
Continuously improve quality systems & procedures with six sigma standards
Develop organization talent pipeline and provide adequate resource support to ensure delivery of business goals
Establish Quality Plans for product development projects

present

Chicago, IL

Quality System Specialist

Chicago, IL

Hoppe, Leuschke and Roberts

present

Chicago, IL

Quality System Specialist

present

Processing Customer Complaints and conducting Customer Complaints analysis
Handling of supplier quality
Handling of product complaint/FCA’s
Consolidating data and monitoring of defined Key Performance Indicators
Using LEAN tools, coordinate LEAN events to troubleshoot and find root cause relating to quality incidents
Performing Quality Training in the organization
Handling of internal and external audit

Education Education

Bachelor’s Degree in Engineering

Quinnipiac University

Bachelor’s Degree in Engineering

Skills Skills

Strong attention to detail
Professional communication skills
Great organization and prioritization skills
Maintains the document management system and ensure compliance to the applicable standards and regulations
Ability to work in fast paced environment
Proficient in Microsoft Office
Maintain weekly Change Control Board meetings to facilitate quicker reviews and continuity of work
Responsible for the maintenance and integrity of the Device Master Record, and Quality System documentation
Responsible for the integrity of the Quality System, Procedures and Forms
Attend project meetings in support of BU/BG goals and Objectives (e.g. MP1, SAP, eDMR)

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15 Quality System resume templates

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Quality System Coordinator Resume Examples & Samples

Ensure the active duties of maintaining ISO/TS 16949 Certification are achieved
Assist the Quality Manager in coordinating the development and implementation of activities related to the Division’s ISO/TS 16949 Quality System Standard
Regular review of Customer bulletins to ensure QMS Customer Specific Requirements are made available to appropriate departments within the Division
Perform Lead Auditor duties for QMS internal auditing including providing audit schedules, providing management with audit results and leading in closing out corrective actions issues
Develop, implement and maintain Document & Data Control Systems for ISO/TS 16949 / ISO 14001 documents, forms and records as well as ECO administration utilizing centralized document control software system. Experience in SharePoint systems is an asset
Develop and maintain Management Reports related to Mafact / KMI (Key Measurement Indicator) like regular Scrap Reduction and Downtime Reports
Develop and maintain all required ISO/TS 16949 and Customer Specific audits like Control Plan / Product Audits, Layered Process Audits (LPA), GM BIQ (Built In Quality), GM QSB (Quality Systems Basic), Corporate GQS (Global Quality Systems), MMOG, etc
Assist Human Resources in implementation of ISO 14001
Lead role in surveillance and registration audits for QMS including coordinating and scheduling third party audits
Responsible for providing Quality Manager and department management team with audit results and lead in closing out corrective action issues
Comply with the applicable responsibilities related to effective quality management in accordance with Quality Management System (QMS) ISO/TS 16949
Assist Human Resources in ensuring compliance with environmental legislation and participate in continuous improvement activities to reduce Divisions environmental impact
Assist in delivery of all training related to ISO/TS 16949, ISO 14001 and Quality System requirements
Ensure that the company’s safety rules, all employees including contractors, sub-contractors and other outside parties follow plant standards and environmental guidelines
Facilitate and promote a work environment based on fairness and a concern for people, in accordance with the principles of the Magna Employee Charter and the Division’s Employee Handbook
Ensure confidentiality of all company related information
Overtime and travel may be required to support achievement of objectives
Minimum post-secondary education – preferably in Quality, Environmental or Engineering studies
Minimum 3 years experience as a Lead Auditor – experience in ISO/TS 16949 and ISO 14001 systems implementation preferred
Minimum 3 years experience in an automotive manufacturing environment. Previous Magna experience is an asset
Working knowledge of English (both oral and written)
Computer literate in Word, Excel, PowerPoint, Project and SharePoint
Quality Systems knowledge and system auditing exposure
Working knowledge of applicable environmental legislation as related to ISO 14001
Excellent ability to communicate and interact with people at all levels, both inside and outside the organization

Quality System Manager Resume Examples & Samples

Ensure China ongoing compliance of consumer goods. Drive the quality system to promote customer product satisfaction
Work with cross functional technical teams to influence to develop quality system and ensure compliance of new product introduction with local regulations
Partner with R&D and QC team to ensure high quality products are transitioned effectively from development to the market
Continuously improve quality systems & procedures with six sigma standards
Drive focused component reliability programs to ensure high reliability and customer quality satisfaction with new products
Detect regulations requiring changes in the business processes. Incorporate into the country Quality System
Approval and review of any marketing related promotional materials and their suppliers

Associate Manager Quality System Resume Examples & Samples

Support an effective quality system for assuring quality of all products sold by
Provide training and development, coaching to staffs. Create a high-performance
Experience in QA or related fields at least 5 years (preferably in consumer product and/or pharmaceutical company)
Experience quality auditing
Good knowledge of GMP and/or equivalent Quality Assurance Systems (e.g. cGMPs, cGxP, Quality System, HACCP, ISO 9000)
Strong communication skill with leadership abilities. Good coordination and interpersonal skills
Good command of written and spoken English together with computer literacy.Quality Systems

Quality System Analyst Resume Examples & Samples

Ensures consistent and correct execution of QS procedures at the site to maintain the quality and compliance of processes and records for NC, CAPA, IA Observations, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR. This includes
University/Bachelor’s Degree or Equivalent
Degree in Engineering is preferred, or associated relevant Scientific / Technical / Quality discipline
Four years related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience is required
Experience in working in a manufacturing / operations environment is preferred
Knowledge of ISO and QSR regulations is required
Experience with root cause investigation, change management, risk management and technical writing is required
Experience in Quality Systems process development, support, integration or enhancement is preferred
Experience in Project Management is preferred
A Certification in process excellence is preferred
Experience with training or coaching others is required
Strong business acumen, interpersonal skills relating to teams with diverse cultures and business practices is required
Strong verbal and written communications skills for multi-level stakeholders
Ability to take initiative regarding innovative approaches to problem solving in a fast-paced, changing business environment is required
Ability to apply principles of logical or scientific thinking, root cause and statistical analysis
Strong verbal and written Presentation Skills
Fluent in English and German

Quality System Coordinator Resume Examples & Samples

Provide site leadership for functions of Quality System, CAPA-NCR responsibilities and/or QS Initiatives, for example: NC, Stop Shipment, GDP site representative
Coordinate data collection and perform analysis for quality metrics, quality improvement initiatives, CAPAs, NCs, or Quality Systems
Responsible to publish department metric data in Global Surgery or Enterprise dashboards and scorecards
Support Quality Operations Lead responsibilities under direction of Quality Operations lead
Act as local Administrator for computer systems driven by the organization (e.g. NCR, CAPA, MES, JDE, process control, etc.)
Perform high level application transactions (i.e. MES, JDE, EtQ) and/or software testing and validation
Collaborate with all Mentor sites in the development and launch of new applications & processes
Drive system & process improvements and ability to coach others in a quality focused direction
Actively influences the team and other fellow workers and seen as role model for Collaboration and Teamwork
BOP, Internal audit and external audit support
Follow J&J and Records Management Policies, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and third party vendor if applicable
Associates Degree or 2 year completion at University, College or Technical Institution required
A minimum of 3 years of related experience required
Computer skills required
Ability to read, interpret and write technical reports in English required
Ability to perform basic statistical functions, such as Pareto analyses required
Ability to define problems, collect data, establish facts and draw valid conclusions required
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables preferred
ASQ certified applicants (e.g. CQIA, CQA, CQT) preferred
Possession of Green Belt preferred
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ability to lift/move weights not exceeding 15 pounds.Quality Systems

Quality System Specialist Resume Examples & Samples

A minimum of 4 years’ experience in quality control/assurance or quality systems in a FDA regulated environment is required
Proficiency in MS Excel and MS Word is required
This is a part time position. Hours of work are Monday through Friday, 20 hours per week. Flexibility in hours will be worked out between work and personal needs
This position will be based out of Raritan, NJ and may require minimal travel as business needs dictate.Quality (Generalist)

Senior Quality System Specialist Resume Examples & Samples

Bachelors degree (science, technology) or experience of similar job
At least 3 years of experience in ISO 13485 certified medical-device manufacturing company
Experience in ISO13485 and 9001, auditing and problem-solving techniques
Good written and spoken English and Finnish, other languages are an advantage
Excellent ability to write documents and describe processes in Finnish and English
Production hygiene, controlled or clean room
ISO 14971, 14001, 17025
Experience of pipetting and lab products including laboratory applications
Statistics knowledge. Able to use statistical software such as Minitab or equivalent
Experience in clean room operation/requirements
ISO 17025 and ISO 14001

Senior Analyst, Quality System Execution Resume Examples & Samples

A minimum of 4 years of experience in a highly regulated industry is required
Quality Assurance/Quality Control experience in the Medical Device, Pharmaceutical, Consumer products or related industry and experience with regulatory inspections is required. Quality Assurance/Distribution Center experience is preferred
Strong knowledge of FDA 21 CFR Part 210, 211 and 820 and/or ISO 13485, 9001:2008, 9001:2015 and/or ERP systems are required
Strong communication, teamwork, problem solving, decision-making, data analysis, inductive reasoning, critical thinking and root cause analysis skills are required
Six Sigma, Lean, 5S or ASQ Certification and trainings are preferred
Proficient experience with Excel is required
The position will be located in one of the Consumer Distribution Centers; Tobyhanna, PA, Fontana, CA or Mooresville, IN.Quality Systems

Quality System Manager Resume Examples & Samples

Complete root cause analysis/causal factor analysis (CFA) for NC items
Identify, evaluate, select and implement the appropriate corrective action plan to eliminate/mitigate the recurrence of NC items
Provide Quality leadership / guidance on all QMS matters as well as product compliance to the facility
Advocate for the VOC (voice of the customer) ensuring customer requirements are realized throughout the life cycle of the products and processes used within the facility from development through product realization and support while in service
Help identify, measure and in collaboration with the Operations and the Quality team reduce Cost of Poor Quality
Establish procedures for maintaining high standards of quality, reliability and safety
Implement and maintain the company QMS in accordance with current quality standards, reporting on performance of the quality system for review and as a basis for improvement
Supporting the site Quality Team to operational excellence supporting the objective of 100% first pass yield, zero customer escapes, proactively supporting 100% on time delivery for the business operations
Acts as the liaison with external parties, including regulatory agencies on matters related to the QMS
Verify, track and appropriately escalate NC/CAPA issues that could impact quality or timelines
7+ years of experience in Manufacturing
10+ years of experience with Quality
1 + years of experience in developing and implementing a Quality Management System
8+ years of experience managing/working a Quality Management System, including CAPA, Non-Conformance (NC), Manufacturing Investigations, Change Controls and Lot Disposition
Certified Auditor
Knowledge or experience with data trending, metrics generation, authoring protocols/reports
Aerospace, healthcare, medical device, pharmaceutical experience
Knowledge and experience with Class 2 Non-Conformance
Experience supporting Class 3 Non-Conformances; experience working with internal or external audits
Familiarity with Lean Transformation process and associated Operational Excellence tools

Manager of Quality System Resume Examples & Samples

Responsible for implementing, maintaining and improving the Quality System in accordance with market and global requirements, such as ISO 9000/ ISO13485, US FDA Part 820
Manages day-to-day operation of the Quality System, including but not limited to,
Bachelor’s degree in a scientific or technical discipline preferred
Must have experience as a Quality Systems Manager in a Medical Device or Pharmaceutical company is preferred
Experience in quality planning, tools and analysis
Good experience with ISO 13485 and FDA medical device regulations
Knowledge of quality system management principles and regulatory requirements for medical devices with the ability to train others
A minimum of 5 years in a development, manufacturing or quality environment
Excellent writing and oral communication skills with the ability to effectively interface with a variety of people at various technical and management levels
Superior time and project management capabilities
Experience in companies with a strong continuous improvement culture is a strongly desired

Quality System Specialist Resume Examples & Samples

Demonstrated knowledge of ISO 9001 Quality Management System / Audit Process is a must
IT Literate with MS Office and Business Object, familiarized with statistical tools/reports is a requirement
Experience of Suppliers Process / Suppliers audit is an asset
Fluent in English – written and verbal, any other language is an asset
Excellent communication skills and able to independently work within a team
Ability to prioritize and handle multiple tasks: analysis, judgments and flexibility
Strong interest for Customer Satisfaction
Have a track record in working under time pressure

Senior Quality System Specialist Resume Examples & Samples

Coordinates and performs daily activities to support the creation of Quality Agreements between multiple sites and divisions
Streamline and improve the process for maintaining and creating Quality Agreements
Responsible for driving high visibility nonconformances and CAPAs to closure in a timely and compliant manner. Lead root cause investigations and develop comprehensive Correction action plans
Lead continuous improvement projects for Quality System Processes including but not limited to NC/CAPA and change management
Liaises with various teams across the business including but not limited to Marketing, Regulatory Affairs, Finance and Operations to collate data in an effective and efficient manner in order to drive continuous improvement initiatives
Provide support for regulatory compliance processes such as Product Field Action assessments and execution
Provide support for Business Development and Merger and Acquisition activities as needed from a Quality Systems perspective
Provide Support for integration activities as needed for Quality Systems processes
Provide support in conducting Internal Audits as required to remain in complianceProvide support during Third Party audits or Inspections

Associate Director, Quality System Owner Resume Examples & Samples

Communication and Influencing skills
Critical and Strategic Thinking
Flexibility / Adaptability
Broad GxP knowledge
Broad and deep regulatory agency knowledge
Owner of one or more of the following Quality Systems
Experience with multiple regulatory agencies across GxPs and regions

Senior Quality System Specialist Resume Examples & Samples

Manages specified quality system processes
Identifies personnel that require training on the relevant processes and rolls out training as required
Represents the processes as required at cross-site meetings
Assists in creating a culture of quality awareness and communicating the quality management system, GMP and associated documents and procedures to all staff

Quality System Manager Resume Examples & Samples

Complete root cause analysis / casual factor analysis (CFA) for NC items
Identify, evaluate, select and implement the appropriate corrective action plan to eliminate / mitigate the recurrence of NC items
Verify, track and appropriately escalate Non Conformance (NC) / CAPA issues that could impacy quality or timelines
3+ years of experience in developing and implementing a Quality Management System
8+ years of experience managing / working a Quality Management System, including CAPA, Non-Conformance (NC), Manufacturing Investigations, Change Controls and Lot Disposition
Knowledge or experience with data trending, metrics generation, authoring protocols / reports
Knowledge and experience with Class II Non-Conformance

Senior Quality System Analyst Resume Examples & Samples

Participates in a cross-functional team of SME’s in the development and improvement of GQO quality or business process documentation, including process maps and knowledge level documentation
Researches, organizes, writes, edits, produces and follows (where necessary) GQO quality system documentation (QSD) for a regulated industry (medical device manufacturer)
Determines training needs for communication of QSD and business process changes with SME’s and supports development of training and testing materials with the Learning and Development (L & D) Department
Coordinates training requirements and release of changes with L & D Department
Supports classroom training with SME’s as required
May conduct training on the Quality System for employees at various levels of the organization
Participates in internal and external quality audits as required
Processes documentation changes utilizing a product lifecycle tool (e.g., Windchill, Master Control)
Support in ensuring compliance of all site GQO procedures with both corporate and division (Instruments and Medical) requirements
May support the coordination of any major changes to the business and quality system which may impact the structure, content, or its databases
Previous technical writing, process mapping, and/or auditing experience a huge plus
Excellent communication, time management, and organization skills with high emphasis on attention to detail
Ability to successfully interface with various departments and personnel
Ability to work independently and motivated to perform at a high-level without constant supervision
Ability to handle multiple projects on an ongoing basis
Ability to adhere to necessary processes within a regulated environment
Ability to understand regulatory requirements and translate into internal business and quality system documentation
Effective analytical, problem solving, organization, and planning skills
Working knowledge of MS Word, MS Excel, MS Visio, and PowerPoint 2007, MS SharePoint, Adobe Acrobat, MS InfoPath 2007, and a document management software (e.g. Windchill or similar software)
Demonstrated written fluency in English

Quality System Supervisor Resume Examples & Samples

Support the current metallurgical group in various areas of the plant to ensure material produced meets and exceeds customer, industry and Alcoa specifications through process control, practice development and inspection systems
Interpretation of multiple Customer Quality requirements across all product categories
Linking Quality Systems (Oracle, Unisys, LIMS, Specifications, Shop Floor, etc.) to ensure customer quality requirements are understood, met and fully documented
Providing direct technical support to AFE Sales and Marketing organizations through product development, process development and technical resourcing
Monitoring key product, process and customer quality metrics and communicating summary and status to the organization on a regular basis
Quality Assurance SPA for maintaining Oracle and Legacy systems
Bachelor's Degree in Engineering from an accredited institution
Minimum of 4 years of experience in Quality Systems and/or Quality Engineering
Experience working with basic aluminum manufacturing processes
Experience dealing with customer quality requirements (i.e. test types, limits, specifications, etc.)
Employees must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available for this position. #LI-FS1
Metallurgical or Materials Science degree from an accredited institution
Previous experience in a unionized environment
Previous relevant work experience of 4 years in aluminum fabrication or metals industry experience

Senior Specialist, Quality System Resume Examples & Samples

Associate degree in Engineering or B.S in Engineering (Preferred)
3+ years as Quality Lead/Technician Position
Working knowledge of Statistics (GRR, SPC etc.)
Change agent with energy, passion and enthusiasm to drive change
This position may require 10% - 15% travel (domestic and international)
Minimum of 5 years of experience required (5 – 8 years preferred) working in regulated environment such as medical device, pharmaceutical, etc
Working knowledge with Calibration systems such as BMRAM preferred
Ability to identify root cause of a problem and creatively problem-solve to gain resolution
ASQ certification in preferred

Quality System Analyst Resume Examples & Samples

Ensure consistent and correct execution of QS procedures at the site to maintain the quality and compliance of processes and records for Quality report and Management Review
Develop competency of resources at the site by providing training and guidance on the execution and documentation of Document Control, Quality reporting and Management Review processes
Support the deployment of process initiatives impacting the site that promote the continuous improvement of the QS and ensure continuity of the application of globally shared processes and systems at site level
Participate in audit readiness; assist in Internal and External audits; serve as Subject Matter Expert during audits; supporting the investigation, response, and remediation of site-specific QS audit observations
0 - 2 years related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience is an advantage
Business fluency in German and in English

Image Quality System Integrator R&D Engineer Resume Examples & Samples

Designs enhancements, updates, and programming changes for portions and subsystems of firmware, including DSP, embedded code, EFI drivers, EFI applications and BIOS/UEFI
Analyzes design and determines coding, programming, and integration activities required based on general objectives and knowledge of overall architecture of product or solution
Writes and executes complete testing plans, protocols, and documentation for assigned portion of application; identifies and debugs, and creates solutions for issues with code and integration into application architecture
Leads a project team of other firmware engineers and internal and outsourced development partners to develop reliable, cost effective and high quality solutions for assigned systems portion or subsystem
Collaborates and communicates with management, internal, and outsourced development partners regarding firmware design status, project progress, and issue resolution
Represents the firmware engineering team for all phases of larger and more-complex development projects
Design, develop, and optimize algorithms to deliver desired output quality, speed, durability, and reliability
Design and run reliability tests to maximize print head performance and maintain output quality over the life of the printer
Develop creative solutions to ink / substrate interaction issues
Understand and develop solutions for system performance issues that affect customer perceived output quality
Develop the key print head control parameters which ensure output quality at maximum speed
Set up and run prototype hardware to answer key feasibility questions
Develop and maintain effective working relationships with other disciplines and strategic partners
O Bachelor’s, Master’s, or PhD. degree in an Engineering/Science related discipline
Bachelor's or Master's degree in Computer Science, Information Systems, Electrical Engineering, or equivalent
Expertise in multiple firmware design tools and languages
Designing firmware, including interaction and integration with hardware design
Firmware testing methodology, including writing and execution of test plans, debugging, and testing scripts and tools

Quality System Manager Resume Examples & Samples

Define and maintain the Quality Management System structure to ensure compliance to Philips Policies, ISO 9001, ISO 13485, 21 CFR 803, 806 and 820, Canadian Food, Drugs, and Medical Devices Regulations (CMDR)and EU Medical Device Regulations
Maintains, enforces, and manages a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels
Establishes the Philips Quality Management System (PQMS) and manages its deployment
Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations
Establishes and executes a transition plan for all QMS in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS
Leads/participates in the maintenance of the quality documents until such time as they are determined to be no longer applicable as part of the PQMS transition
Ensures the addition and management of any local QMS documents in line with the evolution of the PQMS
Ensures training and training registration as per the QMS and generates training content for local QMS documents as necessary

Quality System Process Expert Resume Examples & Samples

Quality Management System process expert, acting in support of the Philips Healthcare Quality Assurance team and Q&R Business Process Owner, across the Philips Q&R network for the E2E program
Participate directly as the Philips Healthcare Quality Management System Expert in Philips “Process Capabilities” deployment programs, in the Idea to Market (I2M), Market to Order (M2O), and/or Order to Cash (O2C) arenas. Ensuring compliance, efficiency and effectiveness of the processes within the Philips Healthcare sector, cross sectors, and at Philips corporate
This entails a thorough knowledge, as example, of Design (I2M), Marketing & Brand & Promotions (M2O), Production & Servicing (O2C) and Procurement /Purchasing

Quality System Specialist Resume Examples & Samples

Understanding of Configuration Management
Understanding of Quality Management System (QMS)
Understanding of the engineering change order (ECO) process
Oversee the ECO process: collaborate with all affected associates, hold weekly change control board meetings, train associates, provide metrics and ensure that ECOs meet QMS requirements
Oversee the Document Control process: File permissions, supporting documentation, etc
Support Project Management teams with documentation requirements
Execute (in SAP) all QMS engineering change orders
Act as Product Hold Coordinator to manage product hold events and ensure adherence to the applicable procedures
Support QMS system integrations
Maintains the document management system and ensure compliance to the applicable standards and regulations
Overseeing all associated document control activities to ensure program fitness and to help ensure that business goals and objectives are met
Maintain vigilance on key performance indicators (KPIs) for bi-annual documentation review and training completeness
Provide periodic updates and escalations on Document Control matters (e.g. backlogs, project statuses, etc.)
Routinely meet with functional managers to strategize and plan tactics to meet project/business objectives
Collaborate with individuals on select items to resolve issues and to maintain continuity of effort
Maintain weekly Change Control Board meetings to facilitate quicker reviews and continuity of work
Attend project meetings in support of BU/BG goals and Objectives (e.g. MP1, SAP, eDMR)
Responsible for the maintenance and integrity of the Device Master Record, and Quality System documentation
Responsible for the integrity of the Quality System, Procedures and Forms
QMS Knowledge is a must

Quality System Specialist Resume Examples & Samples

Review production batch record, system release parameters, and analytical results preparing for release for sale
Involve/support team for investigation of any problems related to product safety, quality, and efficacy
Support necessary training in related to product quality and GMP
Handling of product complaint/FCA’s
Coordinate with the customer and team for investigation for product complaint
Responsible to follow up the corrective and preventive action of product complaint issue
Handling of supplier quality
Evaluate new suppliers and maintain existing suppliers
Coordinate between supplier and team for supplier corrective actions
Conduct supplier audit for new supplier evaluation and maintain existing suppliers
Handling of internal and external audit
Conduct internal audit and follow up as internal audit plan
Coordinate with team for preparation of external audit
Documentation control
Control the QMS document follow Good documentation practices
Process for artwork approval and control
Create training material for SOP by linking to training system
Manage and control training in ISOTrain
Create and maintain courses, modules, and curriculums in ISOTrain
Assign required training to employees as requests
Report and follow up training performance
Bachelor degree in Pharmaceutical with pharmacy license or
Bachelor degree in related field with 3-4 years of experience in Quality system or manufacturing in a Pharmaceutical or Medical Device Company or regulated industry
Having knowledge in GMP, PIC/S., or ISO9001
Ability to interface with all levels of employees, supervisory, and management
Strong communication and people skill
Knowledge of GMP for pharmaceutical manufacturing environment
Good command of English and Computer literacy

Associate Director Quality System Improvement Program Resume Examples & Samples

Thorough understanding of regulatory requirements for pharmaceutics OR medical devices to include risk management OR laboratory control
Minimum 10 years prior site and/or global quality experience in FDA and or EU regulated pharmaceutical, vaccine, biologics, API manufacturing preferred
Ability to accurately interpret and apply regulatory expectations to the Quality Management System in a drug, device and biologics manufacturing environment
Must have strong project management skills

Senior Specialist Quality System Improvement Program Resume Examples & Samples

Thorough understanding of regulatory requirements for drug products and medical devices
Minimum 7 years experience in analytical laboratory at site or drug development
Ability to accurately interpret and apply regulatory expectations to the QMS in a drug products or medical device manufacturing environment

Quality System Document Control Administrator Resume Examples & Samples

Using the E-DMS system, review and format quality system documents, cGMP SOPs, and other forms as necessary
Ensure adequate document control, including versioning, facilitating periodic reviews, approval routing, storage and archiving
Manage and track Change Control documentation
Two-year degree in a technical field, or a combination of equivalent education and experience
High degree of proficiency in the Microsoft Office Suite, particularly Word and Excel
Two or more years working in a GMP environment—pharmaceutical/clinical QA or packaging experience a plus
Demonstrated ability and proficiency
To work independently with a high degree of accuracy per established procedures and processes
To balance multiple projects concurrently
To organize and prioritize appropriately
To consistently provide quality deliverables within agreed-upon timelines or procedure
To collaborate with staff at all levels of the organization
To consolidate information from multiple sources into coherent final content
Certificate in Microsoft Work or Microsoft Excel
Demonstrated proficiency with paper or electronic document management system (E-DMS)

Quality System Product Lifecycle Management Service Engineer Resume Examples & Samples

60% - Leads QS PLM service design and development activities, while following approved J&J standard policies and procedures (e.g. SDLC, Agile, IAPP, etc.). This role requires a broad knowledge of technology / business solutions, leadership and creativity to work within a large IT service delivery organization to drive business solutions
5% - Captures customer insights to improve QS PLM services throughout delivery, and delivers continuous improvement recommendations to service owners. May conduct impact analysis on process/tools coming from new/enhanced services
10% - Assists in knowledge transfer to team members and organizations after successful delivery of the service
10% - Performs assessments of customer demand and partners with order analysts to deliver estimates and quotes for QS PLM service(s) to the customer
5% - May plan, select, and schedule approved vendors to deliver the service. May oversee the work of vendor resources throughout a project
5% - May manage the AS budget for the delivery of the service and be responsible for reporting on service performance to leadership and customers
5% - May develop service improvement plans and/or run service improvement initiatives
Minimum of 7 years of related work experience in large enterprises required
Bachelors or equivalent is a plus
Analytical, and problem-solving skills
Understanding of QS PLM technologies and platforms a plus
Must be able to solve complex business problems and present recommendations to senior management effectively
Must have good planning, organizational, analytical, and decision-making skills
Must be able to define, shape, and drive projects to completion while effectively collaborating strategically with others with little supervision
Must be able to influence others
Experience in Word, Excel, PowerPoint, SharePoint, and other MS office tools required
Strong analytical skills and problem-solving skills required
Results driven, quick learner, and a self-starter required
Position will require 10-15% travel dependent upon project assignments
Web/Middleware: J2EE, Sun WebLogic Server, Sun WebLogic Integration, Sun WebLogic Portal, Sun SOA AquaLogic, JCA, XML, XSL, XSD, WebMethods
PLM/PDM Software: eMatrix ver 8.0 to 10.0, Enovia V6 R2010x, R2011x, R2015x, Engineering Central, Document Central, Specification Central, BOM Management
Tools/Utilities: Eclipse IDE, Clarify, AutoIt, Microsoft Project Plan
Operating System: AIX5.3, Red Hat Enterprise Linux 4.0 - 6.0, Suse Linux 9, HP-UX 11i v2 & v3, Sun Solaris 9, 10, Windows
Databases: Oracle 10g, 11g, DB2 8.1, Sybase 12.5.3
Programing Language: Java, C, C++, Shell Scripting, MQL, TCLInfo Technology

Quality System Specialist Resume Examples & Samples

Candidate must have a minimum of six years of Quality Assurance related experience working in an administrative and documentation control environment is required
Computer literacy in Windows OS, Microsoft Access, Excel, Word, PowerPoint, SharePoint, Adobe Standard and electronic data transfer is required
"For Official Use Only" (FOUO) background check is required
This position requires periods of prolonged sitting, standing, walking, and moving boxes and crates up to 50 lbs

Executive Associate Quality System Improvement Program Resume Examples & Samples

Required: High School Diploma or equivalent
Preferred: Advanced education or certifications such as (e.g. Certified Administrative Professional, Project Management Professional Certification, Professional in Human Resources Certification)
Minimum of (8) years Administrative Assistant experience
Minimum of (3) years Executive Administrative experience supporting senior executives (VP or above)
Advanced computer skills using MS Office Suite (Outlook, Word, Excel, Power Point etc.) and operation of other peripheral devices
SAP experience processing: Expense Reports; Purchase Orders and Payment Requests; Vendor Add Forms, as well as the capability to run reports within SAP
Experience scheduling complex travel arrangements including multi-leg domestic and international travel
Demonstrated experience with processing of Visas/Passports
Advanced secretarial/clerical abilities with a history of high performance
Documented experience as a strong performer in current and past positions
Ability to handle and prioritize a large number of simultaneous assignments
Experience with event planning and coordination
Extraordinary attention to detail
Outstanding communication and people skills
Experience with financial and budget tasks

Quality System Manager Resume Examples & Samples

Develop and manage quality system
Develop and implement QA policies and procedures, document management system, CAPA program and Supplier Quality program
Coordinate and host audits and FDA inspections

Quality System Analyst, Document Management Resume Examples & Samples

A combination of one of the following is required: Bachelor’s degree plus 2 years of relevant experience; Associate’s degree plus 4 years of relevant experience; High school diploma plus 6 years of relevant experience
A minimum of 2 years of related experience including Quality Assurance, Quality Systems and/or Quality Control in the pharmaceutical/OTC or other highly regulated industry is required
A minimum of 2 years’ experience in document management which includes use of an electronic document management system is required
Knowledge of FDA/EMEA regulations and 21 CFR Part 11 requirements as well as cGMP related to documentation required
Prior experience delivering training to colleagues and partners is preferred
Experience providing support for internal audits and inspections by regulatory authorities is a plus
This position will be located in Skillman, NJ, Raritan, NJ, or Bridgewater, NJ.Quality Systems

Quality System Resume Examples & Samples

Support the Company’s QMS certification. Lead and participate in internal, external and 3rd party audit
Assist in all regulatory activities and ensure compliance on all Quality Management System
Maintain compliance with all QMS ISO standards and procedures
Support the effective implementation of quality policies and associated procedures
Involved in customer complaints and assist with providing corrective and preventative action responses
Assist operations with continuous improvement activities
Develop positive relationships and effective lines of communication with all functions
Define, develop and implement new methods and practices to improve product quality
Conduct quality training where needed

Quality System Manager & Lead Auditor Resume Examples & Samples

Keep up-to-date, and ensure compliance with, applicable regulations, guidelines and standards
Perform Supplier Audits and complete requests for Vendor/Supplier questionnaires
Plan and follow up on the annual audit program, performing these audits according to plan and maintaining and developing the audit process
Establishing and monitor KPI/PI for the process, providing reports to senior management
Planning and coordinating inspections conducted by external authorities and customers
Playing a key role as compliance expert in the adaption of ISO 13485:2016
Taking ownership for specific business processes as assigned

Global Quality System Manager Resume Examples & Samples

Contribute to the modification, development, and implementation of company practices and policies for quality and regulatory affairs on a global basis
Work with regional Quality Leaders in identifying and creating AQH Global processes
Maintains all Quality System certifications and serves as a liaison with regulatory agencies as assigned
Work on establishing, reviewing & approving quality control methods and procedures
Ensure Quality KPI alignment of all regions
Oversee the merging of regional quality process into standard global process where opportunity exists
Instill a culture of upholding the highest level of commitment to product quality and customer support
Oversee root cause/failure analysis activities and manage corrective actions for material non-conformances utilizing established quality engineering techniques
Serve as primary point of contact/management representative for all customer and external regulatory/assessment audits
Coordinate continual improvements of the QMS while monitoring the regulatory environment for changing policies, processes and procedures
Extensive experience (7 plus years) with at least 5 years of experience in quality management in a manufacturing environment. Automotive experience a plus
Five or more years of leading people & projects within a global quality environment
Good charisma, Quality Champion effective in building high performing teams
Experience in ISO compliant, lean manufacturing environment
Strong background in international quality system requirements such as ISO 9001/QS 9000/TS 16949
Hands on management style and willing to lead by example
Passionate about implementing Continuous Improvement and Lean Manufacturing processes
Deep knowledge and experience in practicing Advanced Product Quality Planning (APQP)
Statistical Process Techniques, Failure Analysis, and Process Validation experience
Strategic planning, execution, hands on attitude and willing to change
Analytical skills: ability to make analyses relating to quality performance and trends identifying opportunities to improve

Quality System Manager Resume Examples & Samples

Establish and maintain the FDA 21 CFR part 820 QMS in Flex Suzhou
Analysis the gap between FDA 21 CFR part 820 requirements and current procedures, with a general improvement plan to eliminate the gaps
Coordinate with all the related productions and support functions to find the more suitable proposal and implement the plan
Actions follow up / audit and corrections made immediately during the implementation stage
Coordinate the 21 CFR part 820 requirement audits by FlexMedical corporate regulatory team
Actions follow up for the corporate audit results
Prepare to do the self-registration for Flex Suzhou manufacturer with corporate support
Provide quality service to Flex’ internal and external customers in all assigned tasks, while upholding Flex Values at all times
Evaluate business goals, identify improvement opportunities and apply system thinking and problem solving techniques to improve and sustain product quality and process effectiveness
Assist operating units with development and implementation of corrective and preventive action plans to improve overall ISO compliance and quality results
Plan and execute quality system implementation and team activities to facilitate changes, especially as it relates to meeting and exceeding customer expectations
Provide quality system expertise in product development projects, verification, validation and manufacturability involving Operations, E&TD, PM, Material and other departments
Support the maintenance and improvement of the Flex Quality Management System
Schedule and perform audit activities, to include pre-audit planning, audit execution and evaluation and post-audit follow-up and recommendations
Present to managers on improvement projects and activities
Compile & write training material and conduct training sessions on Quality System improvement tools & methodologies
Ensure applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/ modifications related to ISO quality systems
Support the development and administration of the customer corrective and preventative action, internal non-conformance and Flex Quality Management Systems

Quality Shop Director & Quality System Manager Global Propulsion Systems Resume Examples & Samples

Proficiency and knowledge of Propulsion System Manufacturing
Proficiency and knowledge of the elements of Quality Systems, Mfg Quality Processes and Tools
Proficiency and knowledge of Quality Launch Processes and Plans
Proficiency and knowledge of the Propulsion Requirements in GM Global Quality Manual
Coach, Teach and Audit elements of GM Quality Manual and Built-in Quality Principle and Elements
Communicate with Global Quality systems leadership and China JVs to implement best practices, resolve problems, and sustain consistent performance to objectives. Lead critical discussions as needed
Provide technical and leadership direction to less experienced JV/GM China staffs
Managerial Courage to provide direct, honest, constructive feedback to GM China JV Plant Staffs / Executive Leadership in a tactful and professional manner
Ability to travel to GM China JV Vehicle and/or Propulsions System assembly plants as required
Willing to work early or late hours to convey GM or China JV requirements during conference calls
High level experience in Quality Management Systems & Procedures (TQM, ISO, TS, Six Sigma), Built-in-Quality & Quality Launch Processes, Vehicle Development and Powertrain Development Process as it relates to Manufacturing Operations
People Development skills – coaching, mentoring and developing others to become self-sufficient
Experience with Quality Processes as such as FMEA, SPC, MSA, PPAP, APQP, Problem Solving, etc
Knowledge of Vehicle Assembly and Powertrain Manufacturing
Ability to travel (frequently when necessary) for implementing, teaching and assessing BIQ & Launch
Skilled at building relationships across functions, business units and cultures
Proficient English skills (written/speaking)
Effective oral and written Communication skills; comfortable making presentations to senior leaders
Proficient in MS Office applications – Word, Excel, Powerpoint, SharePoint and Outlook
High level organizational skills - ability to multi-task and prioritize numerous assignments
Skillful at Problem solving (both product and process)
Comfortable with ambiguity - able to work within a complex and changing environment
Organizational agility & Cross-cultural sensitivity - Ability to work in matrix organizational structures and completing complex tasks (global, cross-functional) on time
High level of skill to work independently and confidence in decision making
Managerial Courage and confidence to provide direct, honest, constructive feedback to China JV Plant Staffs and Executive Leadership
Bachelor’s Degree in Engineering/Manufacturing/Quality or equivalent. (Master’s Degree preferred)
7-10 years of Quality, Engineering, Manufacturing or Quality System experience
Multi-Sector (vehicle, powertrain, etc) & Multi-discipline (quality, manufacturing, etc) preferred
Lean manufacturing techniques and process experience. (Six sigma or Lean six sigma certification - preferred)
Joint Venture or partnership operations experience (preferred)
Change Management and/or start-up project experience (preferred)

Quality System Specialist Resume Examples & Samples

Above 2 years quality system management working experience in automotive industry
Proficient in Microsoft Office Suite, Adobe, and Photoshop or equivalent software
The ability to fluently speak and write in both Mandarin Chinese and English
Good communication, presentation skills

Quality System Records Resume Examples & Samples

Oversee internal records and ensure compliance with internal and external requirements
Oversee and maintain effective documentation systems and procedures
Maintain device history records (hardcopy/electronic) in conjunction with manufacturing to ensure control and retention of quality records and documentation
Manage the maintenance of an External Standards System comprised of a database, electronic standards library, and secure filing system for hardcopy external standards; work cross-functionally to ensure the most current standards are referenced in procedures, protocols, and reports
Establish, develop, validate, administer, utilize and maintain an electronic document/electronic archival system and associated compliant procedures; continually ensure systems are effective, compliant and meet customer needs
Serve as training administrator (Nobel Campus Administrator); ensure defined and appropriate training requirements and effective documentation for GxP activities; identify training needs and develop, refine and implement curriculum and delivery as needed
Ensure training support and effectiveness for multiple functions throughout the organization; provide support
Work with Senior Leadership to develop, maintain, coordinate and deliver a centralized education and training program to maintain GxP compliance
Under the guidance of the Sr Engineer responsible for the identification, creation and implementation of compliance related training materials and systems
Assists with all Change and Document Control processes including: metrics, review meetings, change approvals, Quality Systems Records, Training & Change Control
Oversee the coordination of document effective dates and the proper release of controlled documents in support of organizational needs
Work with Senior Leadership and cross-functionally to select, implement, maintain and modify software applications related to documentation management and configuration control/management
Ensure availability of current device master record documents
Compile and organize data for use in management review as well as provide support for internal/external audits and inspections
Guide and advise to ensure department goals and objectives are reached
Assist in planning of budgets for records management; ensure fiscal compliance
Lead and/or support continual Quality Management Systems improvement activities
Develop and maintain procedures, documentation and standards, relevant to Document, Change and Records Management, that ensure best practices across the organization
Associates Degree or equivalent work experience
Two (2) years minimum of work experience in similar function preferably within Document, Training, Change or Records Management
Excellent communication skills (verbal, written) required
Presentation / demonstration of strong leadership abilities required
Prior work experience related to document management/control and training within a regulated industry preferred; (medical device or pharmaceutical environment preferred)
Previous experience working on projects and issues with large impact preferred; previous budgetary experience a plus
Strong focus on collaboration and team work
Industry knowledge (ex. FDA QSR, ISO 13485, GMP) a plus
Excellent communication skills required

Director, Global Quality System Training Resume Examples & Samples

Analyses training needs to develop comprehensive global quality training strategy and programs; including need to or modify and improve existing programs
Develops a training needs assessment process and creates a process with appropriate delivery methods and post-training effectiveness evaluations
Reviews and evaluates training program and ensures compliance to applicable standards and regulations, globally
Plans, develops and delivers QS trainings and educational forums, using knowledge of the effectiveness of methods such as classroom training, demonstrations, on-the job training, meetings, conferences and or workshops, such as cGMP, on-boarding, etc
Investigates, develops and implements corrections and corrective actions for issues related to trainings process and applicable system issues
Performs as subject matter expert for QS training process/systems during internal and external audits
Perform as subject matter expert, trainer and educator for the Global Quality Systems Training Program. Responsible for the overall design, assessment, evaluation, implementation and effectiveness of the global QS training process and system
Acts as a global consultant for the business and human resources to identify training needs through job description analysis and regular consultation with business managers and the human resources department
Responsible for the development and maintenance of the Corporate Quality System training matrix
Trains instructors and supervisors (when applicable) in content, techniques or skills for training employees including the development and implementation of train the trainer sessions, globally
Aligns and partners with Global IS team to optimize global learning technology and is accountable to develop training content, including the development of the training scorecard (such as metrics) and reports to measure training program completion as well as effectiveness
Responsible to monitor and track external commitments or observations related to corporate training systems/programs. Ensures these are appropriately addressed to prevent recurrence
Develop corporate training budget and ensure activities fall within the budget
Work directly with IS to ensure systems are configured to handle the business needs and drive continuous improvement
Responsible to perform gap assessments for regulatory requirements changes impacting the organization’s training obligations. Implement changes as needed
Continuously seeks and supports new approaches, practices and processes to improve the efficiency of training services offered
Responsible to identify and implement process improvements projects to ensure harmonization and integration of the training process and system globally in according to the established quality goals and objectives
Works closely with management, ensuring that policies, programs and processes are developed, implemented, communicated and consistently administered in compliance with organizational objectives and with relevant standards and regulations
Selects and manages third party vendors as required
Bachelors’ degree in business, engineering, sciences or other technical field
A minimum of three (3) years’ experience managing corporate or global process within the medical device industry
Experience Harmonizing processes and systems
Proven track record of experience with training compliance in a regulated environment
Ability to represent the company with external constituents

Senior.quality System Data Analyst Resume Examples & Samples

Identify, lead and provide business process improvement solutions for Quality systems, including developing changes to procedures, to improve operation, efficiencies, and user experience 20% of time
Provide first-level help desk support to users, e.g. Audit Management System (AMS), including troubleshooting system issues, (e.g., system access, systems response) before escalating to IT if needed. 30% of time
Recommend changes to documentation associated with Quality Systems, as well as assessing effectiveness and approving recommendations of others 10% oftime
Lead projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources, and representing quality management on cross-functional teams – 20% of time
Determine new training and training program improvement needs, including development of training programs and training materials to address system user problems, and delivers training – 10-% of time
Collect and generate metrics, and draw inferences for system improvement opportunities 10% of time
Bachelor's Degree with 5 years of previous related experience in quality systems (e.g., CAPA Investigations, Root Cause Analysis, Product Risk Assessment, Non-Conformance Handling) required
Experience in a quality and/or manufacturing environment in the medical device industry required
Proven expertise in MS Office Suite
Good project management skills and related software tools preferred
Excellent written and verbal communication skills including negotiating and relationship management skills
Strong problem-solving and critical thinking skills
Good understanding of Edwards policies, procedures, and guidelines relevant to quality systems
Good knowledge and understanding of medical regulations as relating to documentation
Good understanding of medical devices regulations (e.g., FDA (21 CFR Part 820), ISO13485, and ISO 14971)
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

Quality System Contracts Review Analyst Resume Examples & Samples

Self-starter with the ability to meet or exceed deadlines, prioritize, multi-task, and maintain flexibility in a fast-paced, changing environment
Excellent written and verbal communication with legal mindset
Strong interpersonal skills with the ability to work across all functions
Must be proficient in Microsoft Office Suite
ETBF

Director Medical Device & Combination Products Quality System Improvement Program Resume Examples & Samples

Drives maintenance, knowledge transfer, and as needed development of Merck’s Device specific Quality Management System
Works with External and Internal Partners to ensure that effective and robust MDCP Quality Systems and Quality management are in place
Supports the development and implementation of MDCP Quality metrics, procedures and guidelines, as needed
Provides training and coaching to initiate quality improvements within Development, Operations and Quality, as needed
Drives the development/revision of policy and procedures for MDCP Quality and /or supported areas
Supports preparations of regulatory agency discoverable documentation with focus on relevant MDCP regulations and Quality system requirements
Expert knowledge of pharmaceutical and/or medical device regulations and/or compliance in a specialized area with experience in their application, including current GMPs for combination products
Able to speak up and contribute in a team forum
Able to apply prior experiences and learning's in new settings, even if these are unfamiliar
Working knowledge of technical aspects of device development and commercialization

Senior Quality System Specialist Resume Examples & Samples

Write or establish processes, metrics, or procedures to ensure continued process and quality system performance
Design and implement training appropriate to the process or system implemented or improved
Review data, documents and other quality records
Minimum BS degree or equivalent in technical and/or scientific discipline with minimum 5 years of manufacturing/QA experience
Minimum 3 years of experience in project management or supervision, especially in the biotechnology or medical device areas
Proficient with electronic quality management systems and able to use Microsoft products including Excel, Outlook, Visio as well as familiarity working in a windows-based environment
Demonstrated experience in achieving results in a rapidly changing cross functional environment
Excellent oral and written communication skills, including formal presentations and reports
Over 5 years of experience in designing, developing and redesigning Quality Systems in compliance with quality system regulations and standards including QSR, ISO9001, and ISO13485
Independent, self-starter with proven results in problem identification, planning, communication and project management
Ability to work and communicate well with a diverse scientific, business, and organizational groups to achieve improvement and operational results
Ability to articulate technical and interpersonal issues, and resolve conflict in a constructive manner to ensure project success
Certified auditor as recognized by American Society of Quality or similar credentials

Quality System Team Leader Resume Examples & Samples

Lead a small team
Responsible for Risk Management on site
Responsible for the consistent and correct execution of QS procedures at the site to ensure the quality and compliance of processes and records
Management of on-site QPR and QSMR, including coordination, preparation, execution, and tracking of activities
Management of Product Quality Escalations for nonconformances
Maintenance of original documentation for site NC, CAPA, Product Quality Escalation, Site Complaint Manufacturing Investigations, QPR and QSMR as quality records
Collaboration with Franchise Quality in the deployment (design, implementation, and postmonitoring) of QS initiatives impacting the site
A minimum of a Bachelor's Degree in Engineering, Life Science, or related discipline is required
Experience in the medical device and/or pharmaceutical industry
Several years’ experience in a comparable position
FDA and ISO regulations knowledge
Strong communication, teamwork, and problem solving skills as well as root cause analysis skills
Six Sigma, Lean, or ASQ Certification and trainings is an advantage
Business fluency in English and German is required

Quality System Specialist Resume Examples & Samples

Manage and develop the CAPA process and perform effectiveness verification
Work closely with quality engineers and function managers to ensure QS compliance with all ISO and corporate policy procedures
Create and coordinate creation of key procedures and processes based on feedback, set quality goals and to ensure customer agreement fulfillment
Provide Quality System training and consultation
Organize and participate in customer and certification audits
Create quality reports and act as management review assistant
Few years experience in ISO 9001 certified manufacturing company and preferably ISO 13485 certified medical-device company
Excellent ability to write documents and describe processes and procedures in Finnish and English
Experience in quality system standards (eg. ISO 13485 and ISO 9001), auditing techniques and interpreting and transforming the requirements to real life situations
Ability to reach solutions with confidence and integrity
Attention to detail and still understanding of the big picture
Statistical knowledge and ability to use statistical software such as Minitab or equivalent
Quality software experience
Experience of pipetting and lab products including laboratory applications eg. IVD
Experience of metrology, dimensional measurements and functional testing of plastics

Director, Quality System Compliance Resume Examples & Samples

BA or BS degree in a technical discipline, with a minimum of 10 years’ experience in a regulated industry is required. Masters in Business or Field of study preferred
Must be able to lead a multi discipline team
Must be knowledgeable and able to operate under cGMP, cGLP and ISO 13485 regulations
Develop short and long term strategic plans, projecting quality system programs and objectives to support Cantel Medical corporate objectives
Work with Cantel VP, Quality Assurance and Sr. Director Global Regulatory Compliance to assure quality systems are in compliance with ISO 13485, FDA QSR Part 820 and other applicable regulatory standards, including participation in internal and external audits/inspections
This position has cross accountability and interactions with Senior Executive Staff, Regulatory Affairs, Quality Assurance, Manufacturing, Engineering, Supply Chain, Research and Development, and Sales and Marketing
Collaborate with Corporate Regulatory Affairs team to support or lead product submissions and maintain registrations/certificates, product Technical Files, ISO certificates and other product regulatory certificates
Proactively investigate and support opportunities for the continued development of new quality programs/systems

Quality System Integrator Resume Examples & Samples

Bachelor’s degree in Engineering or IT areas
3+ years of working experience in the automotive industry
3+ years of working experience in Quality management and Project Management
Experience in international organizations
English advanced skills

Pharmacovigilance Quality System Business Process Owner Resume Examples & Samples

Establishes process strategy, objectives and long-range roadmap with input from key stakeholders (including business and IT)
Forms strong partnership with business owners and aligns with them on key process and systems decisions, including the prioritization of initiatives
Identifies, develops, prioritizes and implements process improvements
Engages stakeholders across the process including, process workers (SMEs), business owners, leadership and IT to ensure alignment on process and resource priorities; validates the merit and applicability of initiatives across functions
Monitors and reports process performance against KPIs and process health vs. plans. Designs / oversees Performance Management Plan
Gains in-depth understanding of a process, how the SMEs work in the process, process strengths and weaknesses. Is an expert in the process itself (vs. the subject matter expert) and will be called as a process expert during inspections
Responsible for all relevant policies, procedures and training plans related to the process
Synchronizes process and system improvement plans with other business process owners; prioritizes work across processes
Primary point of contact for process and system related decisions; represents end-to-end process(es) in key meetings and with external stakeholders
Actively gathers external benchmarking and best practices as input to process decisions; maintains active knowledge and awareness of all associated regulations
Bachelor’s degree required, Master’s degree preferred
Must have 6 years process management experience
LSS/LEAN certification desired
3-5 years of experience working in a regulated GxP environment desired
Robust understanding of GxP requirements including documentation, training plans and CAPA investigations preferred
Strong relationship management skills, Emotional Intelligence and communication skills required

Quality System & Data Support Intern Resume Examples & Samples

Supports project/departments leaders
Build –up / Maintain project database
Supports organization with administrative work concerning project / department
Use Honeywell tools to report
Supports leaders with preparation of project materials
Assures projects documents are collected and stored
Supports production organization with administration of skill matrix recording
Support organization with administrative work concerning HOS
Respects HSE responsibilities as per internal regulations and Slovak law

Quality System Manager Resume Examples & Samples

Good Bachelor’s Degree in, Quality, Engineering or Industrial manufacturing
Able to use Minitab or any SPC tools to perform data analysis
Solid understanding and demonstrated success with practical applications of Lean Six Sigma tools
Good foundation in principles of root cause analysis, Problem Solving Methodology/8D
Good communication skills in English and Mandarin
Willing to travel as necessary (~20%)
6 Sigma, GB/BB, ASQ certifications
Better experiences on ISO9000 system internal or external auditors
High volume production quality management background

Quality System & Program Manager Resume Examples & Samples

Minimum of five (5) years of experience working with or in automotive markets and customers
Experience leading multi-functional teams
Experience interacting with vendor/supplier/customer
Experience in project leadership
Combined experience working with globally distributed teams, such as across the United States, Asia, and/or Europe
Customer centric mindset
Bachelor’s degree or higher in science/engineering from an accredited university
Experience in manufacturing/product development/quality engineering
Project management certification
Experience of OEM spec-in business
Knowledge and experience to be able to handle PPAP and ISO TS16949

Quality System Lead Resume Examples & Samples

Assess need for additional GMP training and sources and develop training as appropriate
Communicate need for additional training, resources and provide budget feedback to department management
Provide customer service to trainees and managers as needed in support of Quality System training
4 year degree or 5 years experience in a medical device industry in the area of Quality Systems preferred
Strong background developing, implementing, tracking and maintaining GMP and technical training programs preferred
Background in document control function, preferably in a regulated environment
Experience in electronic document management systems required
Ability to appropriately evaluate skills, identify development opportunities and provide effective coaching
Excellent written, oral communication, teamwork, and customer service skills
Ability to learn and train staff quickly and effectively
Computer literate - intermediate to advanced word processing skills; competent in spreadsheet and database application; comfortable in networked environment
Attentive to detail; utilize good documentation practices

Quality System Supervisor Resume Examples & Samples

Bachelors Degree in Chemistry, Physics, Biology or any discipline related directly to Manufacturing Operations or Quality Systems
Work experience in validating processes and procedures, auditing processes and procedures, preferably with experience in ISO 9001
Experience with EPA FIFRA requirements a plus
3-5 years of related work experience with management responsibilities
Proficient in the use of MS Word, Excel or Access and experience in an integrated information system such as NAV (Microsoft)
Professional writing skills, with strong listening and effective communication skills across the levels of the organization
Strong analytical skills to develop and interpret quantitative information
Collaborative and able to function in a team environment
Ability to travel periodically overnight

Quality System Leader Resume Examples & Samples

Coordinate and take responsibility for day to day activities FS and QS Leaders: Control Process audit, analyse and manage Hold and Release programs from early process elaboration stages to finished products, to ensure Mondelez Quality, Foods Safety and consumer satisfaction for all Mondelez brands
Develop and planning suppliers audits and Internal audits, control and approval of incoming goods (raw and packaging materials), in order to guarantee Mondelez Quality. Develop and implementing Quality Chain Management System -QCMS (Quality Procedure Elements-QP’s) for all involved operations departments to accomplish corporate goals, satisfactory international corporate audits, and ISO certification and maintanance
Lab management and control, ensuring quality of raw material, ingredients, packing & finished products through chemical, physic or microbiology analyses
Support Consumer Complaint program for knowing clients and consumer expectations and bringing on time answers
Estimate, develop and control budget and expenses for Qulaity Assurance department
Develop and manage team (Maps, feedback, coaching)
Supervise and administer Personnel, set direction and training to achieve continuous improvement
Know and apply the needed actions in case of an emergency in the organization, described in the Emergency Control Plan Manual
Represent Quality in plant staff meetings and regional meetings. Publish the updated values of the performance indicators to all levels of the organization
Detect non conformities in its department, elaborate and assure the compliance of action plan for the closure of these non conformities
Give support for the maintenance of the ISO 9001, ISO 14001, OHSAS 18001, FSSC 22000 and KIM Management System to achieve optimum results in the product quality, food safety, and environmental performance of the plant, personal safety, organization’s activities, products and services. Know, apply and communicate the quality and Food safety, security and environment policies. Understand and ensure compliance of all procedures of the ISO 9001, ISO 14001, OHSAS 18001, FSSC 22000 and KIM Management System that apply to your area
Bear the responsibilities incumbent upon it as a member of the Food Safety Team of Valencia Plant , declared in the VAL PO QP 7.5-01-518 Food Safety and HACCP
Keep the rules and local regulations regarding safety, hygiene and environment, as well as internal regulations of Mondelez International Valencia Plant
Request, read, understand and apply all the recommendations specified in the “AST” (Work Safety Analysis) that correspond to the function executed to avoid and/or minimize any risk to his/her own safety and health
Report any condition or sub standard behaviour observed in order to control and eliminate them
To maintain in good shape all the personal safety equipment as well as being aware in order to report any damage or lost
Elaborate accident investigation reports as well as maintain the follow up for the action plans determined in each case as a consequence of the investigation process
Actively participate in the implementation and maintenance of the safety, hygiene and environmental management systems
Know, apply and communicate the procedures described in the Emergency Control Manual
Procure the appropriate training about work conditions for new positions and/or relocated workers in his/her area
University degree in Foods, Chemical engineering, Industrial engineering or Foods technology degree
Qualifications in Hazard Analysis Critical Control Point (HACCP), ISO / Quality programs implementations, Quality Audits and procedures, Good Manufacturing Practices (GMP), Statistics Process Control, desirable knowledge on Microbiology
Bilingual or Advanced English level
PC Software: Microsoft Office, Prism
Building effective teams
Timely decision making
Delegation
Functional/ technical skills
Minimum 5 years experience in quality assurance area
Minimum 3 years in Foods Industry
Experience in personnel management and administration
Quality & Food Safety Audit experience
Food legal regulations experience

Quality System Expert Change Control Resume Examples & Samples

Advanced technical education: degree in technical or IT engineering; bachelor or higher degree in natural sciences, or multi year experience with QA processes
Strong knowledge in the key Quality Systems Change Control, Deviation Management and Corrective and Preventive Action processes mandatory
Knowledge of Sparta System’s Trackwise application and/or SAP QM is required
Good knowledge in Good Manufacturing Practices and Pharmaceutical Quality Management Systems
Ability to build and maintain a network of contacts across all sites and appropriate Global Functions, ensuring appropriate sharing of knowledge and expertise across teams
Ability to summarize, write and present technical subjects to Senior Management
Willingness to travel to sites when required (10 – 20%)
Establish and maintain compliant and harmonized Change Control, Deviation- and CAPA Management processes

Senior Quality System Manager Resume Examples & Samples

Implement and maintain Quality Management System Software solution and ensure system validation according to FDA Part 11 requirements
Lead continuous improvement of Quality Systems, such as (CAPA, Deviation Management, and Change Management, Internal audit), and direct the efforts to develop, implement and maintain compliant and effective Quality Systems
Lead cross-functional teams to complete projects, address quality issues and implement quality system improvements
Improve Supplier Qualification Program and ensure compliance with FDA regulations and conduct site audits when required. Support third party audits as needed
Support the promotion, socialization, development and implementation of Risk Management
Interact and influence peers to ensure compliance with internal SOPs and FDA regulations
Maintain current knowledge of GMP Compliance program and of applicable company standard operating procedures for areas of responsibility
Provide guidance on interpretation and application of specified QA/GMP compliance regulations, i.e.: 21 CFR Part 210/211
Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
May interface with regulatory agencies and participates in compliance audits as required
Coordinates with operating entities to ensure that internal audits of quality systems are conducted on a continuing basis, to enforce requirements and meet specifications
May participate in the development of training programs regarding all aspects of quality systems administration
Provide leadership in establishing to ensure all documentation is created, reviewed, approved, and retained in accordance with established procedures and regulatory compliance requirements
Define and lead quality initiatives and engineering projects to improve quality systems, product quality and process capability
Identify and support quality systems improvement initiatives by working closely with Quality Engineer(s), cross functionally and with contract manufacturers
Conduct mock recalls, ensure compliance by working with Contract Manufacturers and Distribution Centers
Process owner for training system, ensure training on new documents, changed processes, and manage records
Prepare metrics in support of trending and management review
Bachelor's degree (B.S.) from a four-year college or university in the sciences or related field is required
Minimum of 8 years of Quality experience in OTC, Cosmetics, and/or Pharma industry
Experience with Quality Management System software is preferred
Knowledgeable in project planning; ISO standards; Statistical analysis of quality data
Software validation; The Food and Drug Administration’s Quality System Regulations (FDA’s QSR)
Ability to read, analyze and interpret data. Ability to write reports, business correspondence and procedure manuals
Ability to effectively present information and respond to questions from groups of managers, suppliers, customers and the general public
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form
Comfortable with and enthusiastic about working in a fast pace environment
A fast-mover who is flexible, able to adapt quickly to changing priorities
Highly self-motivated who can perform with minimal supervision
3/21/2017

Quality System Efficiency Coordinator Resume Examples & Samples

Solving quality problems by managing, coaching and auditing the global 8D process in the plant
NQC cost reductions for various analysis to determine optimal problem solving method
Finding ways to help operation teams in their daily task with focus on increased productivity and/or quality
Sharing the knowledge on CI tools and methods in line with the global guideline based on Lean Six Sigma methodology
Minimum 3 years experience in production environment
Problems solving tools knowledge
Six Sigma team knowledge
Customer orienatation

Quality System Analyst Resume Examples & Samples

Participates in identification and implementation of process improvements related to change management and system management
Prepares and revises department documents including procedures, forms, plans and reports in accordance quality system requirements
Coordinates post change activities including document distribution, electronic checking, procedure training, item master changes and notifications
Review data changes and data concerns, ensure system updates and controls are implemented
Perform ad-hoc data investigations when necessary and as part of a team, profile and analyze data to address inquiries and monitor data quality and integrity
Promptly coordinate and complete routine system changes required for project teams
Develop & run reports from various systems (ERP, LMS, PLM) to aid in investigating quality issues
Assist in the development of business processes to drive efficiency and accuracy in the quality business process
Assist with internal and external audits
Process and prepare monthly metrics as required for management
Drives continuous improvement in document and data control systems

Quality System Manager Resume Examples & Samples

QA professional with first hand knowledge and experience in US FDA CFR 21 part 820 and ISO13485 quality management systems within a medical device environment
Clear understanding of good manufacturing practices
Experience for auditing under ISO9001, ISO13485, ISO17025 requirements
Knowledge and experience of International Quality standards & Marking ( ie ISO13485, ISO17025, ISO9001, Medical Device Directive, CE mark, and product marks ie
Experience on investigation, problem solving, data analysis, recommend corrective/preventive action
Experience on change management program, risk analysis
Experience on conduct supplier audit base on international standard requirements
Degree in science based subject, ideally with additional qualification in Quality management systems
Highly motivated self starter, flexible, proactive with excellent communication skills and the ability to influence people at all levels

Quality System Spec Resume Examples & Samples

Assistance with the CAPA process, depending on experience including management of the CAPA system to ensure system adequacy, including remedial actions, with regards to CAPA initiation, processing, tracking, closure and follow-up
Support the compilation and review of quality system metrics and summaries
Maintain department records and files
1 year of experienceSearch Jobs US

Quality System Analyst Resume Examples & Samples

Ensure consistent and correct execution of QS procedures at the site to maintain the quality and compliance of processes and records for Quality Report and Management Review
Develop competency of resources at the site by providing training and guidance on the execution and documentation of CAPA, Non-Conformity, Quality Reporting and Management Review processes
Manage on site CAPA and Non-Conformity activities and represent these processes as local Subject Matter Expert
Minimum of 2-4 years related experience in Medical Device or Pharmaceutical environment
Experience in NCs, CAPAs, Audit observations, Product Quality Escalations
ISO 13485 and QSR regulations knowledge
Experience in Quality Systems
Experience in taking part in Audits (FDA, TUV, BSI, ANVISA)

Quality System & CI Engineer Resume Examples & Samples

More than 5 years quality assurance and Quality system experiences in electronics company(Mandatory)
Very strong problem solving skills (Mandatory), be familiar with 8D, 5 why analysis
Develop and improve the manual, procedure and working instruction documents for quality system
Organize the internal audit and external audit, and monitor the improvement action
Develop CI plan and lead monthly CI review and achieve company CI targets
Organize and implement CI training to promote CI awareness
Good communication skill and coordinate ability
Electrical major, bachelor degree is preferred

Senior Quality System Supervisor Resume Examples & Samples

This role is responsible for monitoring and maintaining the plants Quality systems to ensure compliance to regulatory, federal and local laws. Areas of focus will include the identification and achievement of facility Quality KPI's through appropriate corrective/preventive actions and continuous improvement initiatives. This role will actively participate in all internal and external auditing activities and follow-up. Further, this role will act as support for QCMS/ISO; QRMP and HACCP functions will lead the development of new quality systems/programs across the facility and will provide Quality support/resources for major commercialization projects
Ensure all Specification/KPI/QCMS/QRMP/FSSC/ISO/ plans are maintained and updated/approved as required. Co-lead plant bi-annual validations
Train site on proper inspection procedure practices. Assist in insuring facility is inspection ready at all times. Provide Quality/Sanitation support for project commercialization
Insure proper construction procedures are followed to meet site/Kraft Food safety requirements. Takes appropriate steps to assure successful project startups
Acts as Distribution Quality contact and work with Distribution on Quality concerns/initiatives. Also, assists with product disposition and security items
Supports and follows proper plant safety policies and procedures
SAP Quality Data Steward role and maintaining compliance
Support and/or lead Quality functions as directed by Technical Services Manager

Quality System Manager Resume Examples & Samples

Establish Quality Plans for product development projects
Provide guidance for application of Design Control i.e. Design and development planning, Design input (e.g. specifications), Design reviews, Product verification and validation, Risk management, Usability engineering and Design transfer etc
Serve as the Division’s Risk Manager, which includes ownership of the process as well as providing training for and follow-up of the Risk Management process
Give guidance on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards
Support post-market design changes, including assessment of proposed changes using design control methods
Participate in team projects and assignments, facilitating or leading teams as necessary
Identify opportunities for continuous improvement of the Quality Systems
Have in-depth knowledge of working with quality management systems in an IVD/Medical device environment (e.g. QSR, EU medical directive, ISO 13485, ISO14971) for a number of years
Have strong interpersonal skills and drive cross-functional collaboration
The drive to bring tasks and projects to a closure
Good organizational skills and the ability to define and achieve objectives for applicable projects and the processes
The ability to work independently, influence and negotiate with people and resolve issues
Have an ability to make rational, objective and appropriate decisions relating to company and department needs

Quality System Specialist Resume Examples & Samples

Continuously drive the facility's culture toward a higher level of safety. Challenge status quo safety behaviors, engage in Safety initiatives and ensure safety related training is attended by all employees
Ensure the job functional activities remain in or exceed the standards and specifications established by Quality Assurance
Drive key performance within area of responsibility and participate in making recommendations for necessary changes to enhance the business objectives
Initiate and drive continuous improvement activities within the responsibilities of this position, its department, and other areas of the facility as part of the team to ensure plant sustainability
Ensure good business communication practices are engaged at all levels to ensure key stakeholders are well informed, have the ability to appropriately respond
Responsible to provide assistance with implementation and enforcement of corporate quality policies and procedures
Participates in the development and maintenance of the facility HACCP program
Provide GMP, Food Safety and Food Security training to all new hires and plant employees
Responsible for quality assurance coordination and maintenance with the SAP inventory systems
Responsible to ensure the facilities product recall program is effective and in compliance with DFA, FDA and customer requirements
Ensures that raw material and packaging specification manuals are accurate and current
Provides support with new product startup by implementing customer and R&D specifications and documentation
Participates in quarterly quality systems audit and monthly facility GMP and Food Safety audits
Support as needed to perform LACF record review, finished product releases and laboratory testing
Manage all project work as defined by the QA Manager
Follows all DFA GMP's and works in a manner consistent with all corporate and regulatory, food safety, quality and sanitation requirements
Maintain and track the Quality system to ensure we are meeting SQF specifications
Participate in monthly internal GMP inspections
Must adhere to all safety policies and procedures
Other duties may be assigned as required that are within the FLSA status of this position
Training Specialist or Educator (Primary or Secondary Ed)
3-5 years of Quality Assurance in a Manufacturing environment
ASTD (American Society of Training and Development) associated

Quality System Coordinator Resume Examples & Samples

Maintain effective relationships with staff and leadership peers
Excellent leadership, customer and internal communication, negotiation, and team building skills
Able to work with minimum supervision and independently
Ability to function strategically and handle multiple projects simultaneously
Understanding of microbiology, aseptic sampling, methods, and interpretation
Proficient in computers including spreadsheets, statistical programs, and SAP applications
GMP & HACCP certification is an added advantage
Good writing, statistics (SPC and charting), analytical, and critical thinking skills
Degree in Science or Engineering
5 years manufacturing experience, preferred in food manufacturing
At least 5-7 years experience in a variety of disciplines including GMP, Sanitation, Quality experience

Quality System Specialist Resume Examples & Samples

Lead ongoing and yearly review, creation, revision and certification of all Production work instructions culminating in final approval by Technical and Operations Leader, Revise Work Instructions as needed to include Management of Change
Serve as the management rep for the ISO process and oversee Document Control Process, Maintain ISO and Lab Manuals, Management Review, Coordinate and facilitate ISO internal audit schedule
Perform ISO audits
Log Customer Complaints from CRM into plant CAR Log and issue CAR form to individual responsible for Green Bay issues. Assist with Calhoun issues as needed
Work with core Lab Technicians to ensure test methods are standardized and aligned with divisional methods
Maintain and troubleshoot Lab equipment as needed, including working with vendor on preventive maintenance programs in collaboration with the Lab Support Specialist
Responsible for lab equipment calibration, preventive maintenance, troubleshooting and issue resolution in collaboration with the Lab Support Specialist
Assist in Quality Metrics tracking. Analyze and identify potential problems
Using LEAN tools, coordinate LEAN events to troubleshoot and find root cause relating to quality incidents
Oversight of defect tracking process
Document and report Issue Free Shipments information

Business Quality System Resume Examples & Samples

Work with the BQS Director, BQS Manager and OneSEA BQ Community to identify opportunities and create initiatives to harmonize quality processes across sectors and countries
Manage the planning and execution of Internal and Supplier Audits in LOCs from Auditor Qualification, Schedule and Agenda preparation to Audit execution
Support in preparation for JJRC Audits, and participate in assessments when appropriate. Review recommendations of auditors and assist in the generation of mitigation actions/corrective action plan for BQS process related observations
Lead or support Quality System initiatives to develop and roll out standardized IT systems, processes and training across OneSEA to meet BQ needs and promote consistency and simplification
Support the Qualification and Training process through maintenance of OneSEA Training Matrix, deployment of OneSEA Training topics in Summit Learning Management System and generation of training completion reports for Management review
Support adherence to J&J Quality Policy (POL1) in OneSEA, while promoting consistency of processes and systems employed by OneSEA LOCs
Support compliance to all J&J Quality Policy and Technical Standards and regulatory requirements, where applicable, including Internal Audit, NC/CAPA, Change Control, Document Control, Quality Records Management and Regulatory Standards Management
Degree qualified from an accredited university
Relevant business experience in quality role, and have good understanding and a desire to develop the quality management system within OneSEA
Background on internal and supplier audits, and compliance knowledge preferably on ISO standards
Sufficient knowledge on J&J Quality and Technical Standards, BQ SOPs, Sector/Regional procedures, GxPs, regulations, and other quality systems and guidelines
Working knowledge of quality and operations systems and processes
Leadership, collaboration, and interpersonal skills.Communication, presentation and management skills
Displays initiative and able to independently create and deliver
Quality and organizational sense.1700171797W

Quality System Support Analyst Resume Examples & Samples

Bachelor’s degree in a social science, science, business, engineering, or related discipline
1-3 years working in a regulated environment to support of electronic systems
Knowledge of EtQ Reliance and CompliantPro administrative functions
Knowledge of Relational Database concepts and design
Quality Management Systems experience Skills
Strong interpersonal skills including the ability to understand user questions/needs and interact with a diverse group of customers
Team player who can provide coverage when other team members are not available. Motivation to increase knowledge of assigned systems and processes
Proficient in software applications like Excel, Word, Visio, PowerPoint
Effective organization and time management skills, with ability to work under pressure and adhere to project deadlines
Demonstrated proficiency in analytical and problem-solving skills

Senior Quality System Coordinator Resume Examples & Samples

High School Diploma minimum, 2- or 4-year degree desirable
Demonstrated experience with data analysis and reporting (2-3 years desirable)
This individual should possess broad knowledge in Quality Performance Reporting with strong computer skills in Spreadsheet management, PowerPoint development and database queries
Documented record of delivering Quality Performance information that adds value to management's decision making process
Demonstrated ability to understand and comply with applicable FDA and other international regulations and Company operating procedures, processes, policies, and tasks
Must be skilled at delegation, follow-up, and team building. Must be able to work cooperatively and productively with others
Demonstrated verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills are essential
Advanced demonstrated personal computer skills including spreadsheet skills, word processing, data base management and other relevant applications
Ability to travel approximately 5-15%, including internationally
Occasional or Regularly scheduled overtime is a requirement of this position

Head of Quality System & Quality Validation Resume Examples & Samples

Lead the Site Quality Systems & Validation program to ensure effective and efficient service to the assigned PT Site
Develop strategies and plans for Quality Systems & Validation for site in collaboration with senior management
Review and approve all relevant Quality Systems & Validation and other Site documentation and ensure documentation supports a compliant state
Provide expert interpretation and application of regulatory guidelines to ensure operations, facilities and documentation meet Roche standards and regulatory requirements
Act as a liaison (and/or SME) to present Quality Assurance and Quality Validation practices to Health Authorities and regulatory agencies
Support regulatory inspections and provide audit support with your team, which may include presentations and facility, utility, equipment documentation review

Quality System Specialist Resume Examples & Samples

Assisting project teams on compliance with FDA QSR, European MDD, ISO 13485 and other applicable ISO/EN standards
Reviewing and ensuring records from processes are complete, accurate and properly filed
Great organization and prioritization skills
Exposure to working in a regulated environment is desired

Quality System Compliance Manager Resume Examples & Samples

Bachelor of Science or Engineering degree (BA/BS) with Audit, Corrective Action system and Quality Engineering experience , or proof of equivalent work experience and training or equivalent combination of education and experience with supervisory and/or managerial experience
Lead internal and external auditors in a professional manner
Maintain accurate Compliance files and records
Thorough knowledge ISO 13485, EN46001, MDD Requirements, FDA's QSR Regulations
Perform internal training of QSR Regulations and ISO Standards
Perform statistical analysis and defect trending for management review
Ability to use Microsoft Word, Excel, Access Trackwise and SAP R/3
Self motivated
Professional manner
Highly skilled in defining and documenting problems, establishing facts and draw valid conclusions
Ability to interpreet and report on an extensive variety of thechnical instructions in mathematical or diagram form while dealing with multiple abstract and concrete variables
Knowledgeable in ISO 13485, EN46001, MDD Requirements, FDA's QSR Regulations

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