Senior Quality Systems Engineer Resume Samples

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D Leannon

Darion

Leannon

990 Keyon Tunnel

Philadelphia

+1 (555) 284 5458

990 Keyon Tunnel

Philadelphia

Phone

p +1 (555) 284 5458

Experience Experience

Dallas, TX

Senior Quality Systems Engineer

Dallas, TX

Metz-Ruecker

Dallas, TX

Senior Quality Systems Engineer

Establishes personal quality improvement goals
Establishes and promotes a work environment that supports the Quality Policy and Quality System
Manage and document configuration changes to the MasterControl Quality Management System
Develop, validate and deliver training on the MasterControl application and other Quality Management System processes
Leads teams to identify and analyze improvement opportunities; leads execution of such process improvement projects utilizing lean six sigma tools
Leads in the development, review, and improvement of manufacturer quality plans and manufacturing processes related to FMCNA products
Manage the improvement of the system through the issuance, control and monitoring of corrective actions (RAC´s)

present

Houston, TX

Senior Quality Systems Engineer

Houston, TX

O'Connell and Sons

present

Houston, TX

Senior Quality Systems Engineer

present

Lead Management Review meetings with Quality Management support, and develop Management Review presentation materials and meeting results/minutes
Provide expertise in Quality Assurance and process improvement tools and methods to support continuous improvement actions
Provides suppliers and supplier development engineers with technical oversight and expertise in the area of Quality Management Systems
Maintains knowledge of all processes and quality principles to assist with daily operations and continual improvement activities
Executes and supports deployment of a global, enterprise-wide Supplier Quality Management System (Supplier QMS) and its integration into the enterprise IR QMS
Provide Business Unit oversight to Quality Management System, across two sites
Partners with Supplier Quality and Development stakeholders in development and maintenance of strategic A3

Education Education

Bachelor’s Degree in Science

Kaplan University

Bachelor’s Degree in Science

Skills Skills

In-depth understanding of the AS9100 standards, implementation and certification process of Quality Management System
Quality Documentation, creation, process flow mapping/development, Project Planning, and implementation
Strong analytical and problem solving skills
Strong PC skills with proficiency in MS Office (Word, Excel, PowerPoint)
Working knowledge of CMMI Standards, Implementation, and methodologies
Working Knowledge of ISO9001, TL9000, Quality management System standards, with direct audit experience & accreditation desired
Excellent written and verbal communication skills
Strong organization skills
Knowledge of project management techniques (e.g. Job descriptions, Quality Agreements, etc.)
Strong analytical, organizational and communication skills and have the willingness and ability to work in a team environment

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13 Senior Quality Systems Engineer resume templates

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Senior Quality Systems Engineer Resume Examples & Samples

Ensure compliance across all aspects of the operation to the requirements of ISO 13485:2003 Quality Management System
Responsible for Complaint Management. Works with Cross Functional Teams in coordinating investigations, determining root cause, implementing Corrective and Preventive Actions arising from the investigation. Generates Customer Reports arising from these investigations
Management of Internal Audit Process. Generates Internal Audit Schedule, coordinates audits and associated Corrective/Preventive Actions. Ensures audits are carried out and followed up in timely manner
Preparation/Management of Customer Audits and External Body Audits
Management of Corrective / Preventive Action System. Responsible for reviewing status, content and timelines of Corrective /Preventive Actions
Direct responsibility for managing Document Control System
Generation of Quality System Metrics e.g. Complaints, CAPAS, Audits etc
Generation of Management Review Presentations
Ensuring Risk Management and Validation Strategy are current and best practice
Communicates updates to Quality System Requirements

Senior Quality Systems Engineer Resume Examples & Samples

Provide Business Unit oversight to Quality Management System, across two sites
Manage QMS compliance activities - leading Internal Audits, Corrective/Preventive Action completion, Quality Training, Document Control and 2nd and 3rd party audit activities
Lead and support initiatives to help the organization meet deployment goals for ACE (Achieving Competitive Excellence)
Provide expertise in Quality Assurance and process improvement tools and methods to support continuous improvement actions
Lead projects to drive standardization of Quality Management Systems and standard work to ensure quality systems and processes are established, maintained and improved upon
Provide quality interface and expertise between the organization and its customers to proactively assure that their needs and expectations are understood and satisfied

Senior Quality Systems Engineer Resume Examples & Samples

Functional management representative responsible for compliance of products and processes used internally (and possibly externally) in the production of aerospace and industrial/commercial products
The Voice of the Customer advocate within the organization
A functional leadership role in product and process compliance to ensure safe and reliable products
Serves as primary liaison for Quality Clinic functions and all related departments as required and QC goal achievement
Coordinates the Corrective Action Board (CAB) process, facilitates improvement opportunities to reduce the Cost of Poor Quality (CoPQ)
Provides Quality leadership/guidance on relevant QMS matters as well as product compliance to the organization. Ability to make decisions that always protect product safety for products and services provided. Ability to properly balance compliance practices with other business initiatives to avoid conflict and allow all objectives of the business to be satisfied
Drive the development and effective implementation of robust processes that are used to control all aspects that may affect Quality of the product or service being provided. Also responsible for the continuous improvement of these processes. Active support and participant of continuous improvement
Coordinate and/or drive the daily activities of the functional Quality organization ensuring adequate resources are in place for compliance, cross training is happening to maximize the Quality staff. Daily interface with operations staff on Quality matters. Responsible for Quality Assurance shop floor support through the Satellite QC program. Serves as mentor to Quality Team members

Senior Quality Systems Engineer Resume Examples & Samples

Will act as an expert resource in external regulations and standards requirement knowledge for cross functional teams. Is viewed as a leader in the areas of quality systems and ISO/MDD standards within one's own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis
Implementation of internal requirements and external laws, regulations, guidance's and standards as applicable to quality systems
Champions continuous improvement and innovation from a quality system perspective
Lead and support site External Inspections
Identify areas of potential noncompliance or improvements by managing and conducting internal audits to schedule
Educate functional areas on quality system requirements
Participate cross functionally and across business units to standardize Quality System policies and procedures
Collect and analyze business/quality system process data from different parts of the company
Support the site corrective and preventive actions process
May on occasion be required to travel in order provide support the business or other sites in this area of responsibility
Is an effective team member and leader, fully motivated to achieve and demonstrate best practices in line with the department objectives
Level 8 quality qualification and 3/5 years relevant work experience

Senior Quality Systems Engineer Resume Examples & Samples

Assists the Quality Systems Manager to maintain the integrity of the documentation system and associated documentation
Serves as the liaison between the division documentation/change control system and the documentation/change control systems located within the manufacturing facilities
Provides training on the documentation/change control system and associated policies and procedures as well as other elements of the quality system
Assists with management of training activities and provides formal training and follow up reinforcement as needed to assure deployment of the quality system procedures
Manages the Document Control and support staff to ensure proper implementation of their duties and responsibilities
May serve as a QA representative in developing and maintaining Division policies and procedures
Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department
Demonstrated management skills
Proficient in the use of a personal computer with intermediate level of keyboarding skills and advanced level of Excel and PowerPoint capability
Strong interpersonal skills required in the areas of verbal and written communications, customer focus, service to internal customers, professionalism, coaching, influencing, and team building
Detail oriented, committed to accuracy, efficiency, and consistency
Working knowledge of medical device manufacturing system requirements- 21 CFR 820, EU Medical Device Directive required. Familiarity with Canadian CMDCAS system, Australian TGA, Japan PMDA, and the relevant elements of quality management requirements preferred
Experience in applying quality auditing, quality engineering and failure investigation principles or equivalent preferred
Ability to assimilate and apply new technologies and innovations to current needs
Ability to travel – 10-20% as determined by business requirements with potential extended assignments at other facilities to resolve problems
Ability to develop concepts and present them in a large group setting
Ability to work with and motivate personnel in other departments
Effective problem solving techniques and leadership
Knowledge and understanding of document control/change control practices, FDA Regulations and ISO Standards, Design Control System, and automated document control/change control systems
Ability to collect and analyze quality data and provide technical support (including statistical analysis) to the Quality System Manager and other team efforts
Four-year Science, Engineering, Technology, or Business Degree; higher education a plus
Seven (7) or more years of equivalent quality system or quality engineering related experience
ASQ, CQE, CQA, certification preferred

Senior Quality Systems Engineer Resume Examples & Samples

Executes and supports deployment of a global, enterprise-wide Supplier Quality Management System (Supplier QMS) and its integration into the enterprise IR QMS
Owns Global Supplier Quality Manual including responsibility for ongoing communication and deployment as well as future manual improvements
Develops standard tools and business processes relevant to the Supplier QMS including procedures, templates and work instructions
Partners with leadership to vet and achieve alignment on new and revised standard tools and business processes
Deploys new/revised standard tools and business processes globally, through formal training and informal coaching, to include internal IR personnel as well as external suppliers
Monitors compliance and deployment effectiveness of the Supplier QMS through various activities such as (but not limited to) supplier audits and internal IR audits
Drives continuous improvement of Supplier QMS based on targeted improvement areas identified during supplier and internal IR audits, Operational Excellence activities, etc
Supports the deployment of IR QMS ensuring alignment with Supplier QMS
Provides suppliers and supplier development engineers with technical oversight and expertise in the area of Quality Management Systems
Leads training of internal staff, along with other functions, on Supplier Quality and Development policy, procedures and work instructions
Owns and leads Managing for Daily Improvement (MDI) process including cross-regional coordination of metric board maintenance, participation in functional Gemba walks, and corresponding continual improvement processes
Participates in problem solving activities including Rapid Improvement Events, formal 9 Step problem solving events, basic problem solving activities, and “just do it” tasks
Partners with Supplier Quality and Development stakeholders in development and maintenance of strategic A3
Partners with Value Stream Coaches and Change Agents to support Global Procurement Operational Excellence Deployment Plan and to deploy identified Lean principle and problem solving training
Bachelor’s degree required. Degree in technical or engineering discipline strongly preferred
Minimum 6 years of experience in Quality or Supplier Quality/Development role (automotive experience strongly preferred)
Minimum 3 years of experience in establishing quality systems, processes, and/or procedures (automotive experience preferred). Experience should include demonstrated procedural development, stakeholder vetting/alignment, deployment planning/execution, and training of personnel at diverse organizational levels
Extensive experience utilizing and/or training quality tools/methodologies including, but not limited to, APQP, PPAP, MSA, SPC,
Supplier audit and/or internal audit experience with IS0 9001 Lead Auditor certification preferred
Demonstrated capability in coaching suppliers and/or internal company personnel in quality management systems
Knowledge of Industry specific quality registration (ISO9001/TS16949)
Working knowledge of Lean methodology and related tools
Excellent interpersonal skills with ability to effectively communicate at all levels within the company
Ability to work cross-functionally and cross-culturally within a matrix organization
Speaks English as a primary/secondary language
Ability to travel up to 25% both domestically and internationally

Senior Quality Systems Engineer Resume Examples & Samples

A minimum of a Bachelor's degree is required. A degree concentration in Engineering, Life Science, Physical Science, comparable work experience, or a related field is an asset. An advanced degree is preferred
Minimum 4 years of experience in a regulated industry (medical device or pharmaceutical) is required. Strict attention to detail. A minimum of 3 years of in a quality role is required
Effective leadership and/or extensive experience with CAPA, Management Review, Non-conformance Management, Internal Audit and Quality System Trend Analysis are required
Quality Systems experience in an FDA-related environment is strongly preferred. The ability to independently analyze data, identify trends, formulate and implement corrective action to improve overall quality systems compliance, effectiveness, and efficiency will be needed
Must be able to work in an open office environment
Strong written and oral communication and interpersonal (listening) skills
Must have ability to lead efforts aimed at the identification of problematic situations, the reporting of issues, and the development of resolutions and decision making
Post market regulatory, quality or compliance areas preferred
Familiarity with basic quality tools and techniques
Analytical and Critical thinking skills are essential

Senior Quality Systems Engineer Resume Examples & Samples

In-depth understanding of the AS9100 standards, implementation and certification process of Quality Management System
Moderate understanding of the requirements of customer-specific Quality System certification programs
Quality system audit related experience (ISO, AS, etc.) required
Experience in managing QMS compliance activities - internal audits, corrective/preventive action completion, and document control
Strong PC skills with proficiency in MS Office (Word, Excel, PowerPoint)
Interpersonal and team building skills
Listening skills
Position requires the ability to communicate with all levels and organizations within UTAS as well as with customers
Six Sigma or ASQ Certification and knowledge of ACE Operating System preferred
10-20% local travel is required (day travel within 20 miles)
Must be able to verify U.S. Person Status as defined by International Traffic in Arms Regulations (ITAR)

Senior Quality Systems Engineer Resume Examples & Samples

Supports the process for maintenance of Notified Body certificates and through partnership with the Ethicon Notified Body for updates and renewals of certificates
Leads/supports significant Quality System projects effectively using a working knowledge of project management techniques (e.g. Job descriptions, Quality Agreements, etc.)
Supports internal and external audit/inspections
Leads/supports Integration of new facilities/businesses into the Ethicon Quality Management System
Provides guidance and direction throughout the organization, sites and functions, for quality system processes
Supports the implementation of regulatory standards as well as internal JNJ standards
Leads change for process standardization, simplification, efficiencies through the use of process excellence tools/methodologies
A minimum of a Bachelor’s Degree is required a concentration in a Science related field or Engineering is preferred
A minimum of 5 or more years of related medical device or other highly regulated industry experience is required
Knowledge of ISO and QSR regulations, ISO 13485 is required
Influencing skills, organization, and communication skills are required
Prior work experience in an FDA regulated environment is preferred
Prior experience working with notified body is preferred
Strong knowledge of statistical methods is preferred
Process Excellence (Six Sigma / Lean etc.) experience is preferred
Expert level MS Office (Excel, Word, Outlook, Visio) skills are required (knowledge of VBA preferred)
Strong conflict resolution skills, project management skills, analytical reasoning and the ability to work in a cross-cultural environment are required
Superior oral and written communication skills are required
Knowledge of project management techniques (e.g. Job descriptions, Quality Agreements, etc.)
This position is located in Somerville, NJ or Cincinnati, OH and may require up to 10% of both international and domestic travel

Senior Quality Systems Engineer Resume Examples & Samples

Practices, mentors and develops company concepts, policies and procedures. Is familiar with and follows standard practices
Contributes to the overall compliance of RDH’s QMS with respective regulations and standards, and implement updates or improvements as needed
Implement changes to the QMS to ensure alignment with Roche divisional standards, including communications and interactions with employees from other Roche business areas/units
Establish and maintain QMS related processes and procedures between RDH and its internal business partners
Manage the corrective/preventive action (CAPA) process and tool calibration program
Support other Quality Management System processes
Support product quality related topics through e.g. Nonconformance Process, CAPAs, Complaint Handling support and other processes
Write SOP’s as well as other quality documents
Develops metrics to measure quality processes and performance, oversees the review and trending of data, identifies opportunities for improvement, and provides feedback to management

Senior Quality Systems Engineer Resume Examples & Samples

Strong analytical, organizational and communication skills and have the willingness and ability to work in a team environment
Proficiency in the AS9100:2016 standard and the CMMI-DEV V1.3 model
General knowledge of design and development processes and manufacturing operations
Data analysis, objective-thinking, judgment and leadership skills
Detail oriented with the ability to manage multiple priorities
Basic understanding of statistics to help quality leadership in process capabilities, metrics and control plans
Minimum 4 year college degree or an equivalent combination of relevant education and experience, preferably a bachelor’s degree in science, engineering or other technical fields
Minimum of 3 years experience with AS9100 QMS is required
CMMI experience is a plus
Must be able to acquire a Security clearance

Senior Quality Systems Engineer Resume Examples & Samples

Develop, review and approve Quality System documents/SOPs/work instructions as required. Review Engineering Change Orders and Device History Records supporting device design and manufacturing, and communicate necessary changes to applicable department representatives to maintain compliance. Work with other departments to train and educate where necessary to ensure procedures are adequate
Support New Product Introduction design & development meetings; create/review/approve device master records, quality control plans, engineering/production risk analysis, labeling, engineering verification & validation reports, production process validation reports, and engineering change orders for adequacy/compliance prior to device transfer to production
Lead internal audit program, including internal audit scheduling, planning, corrective action initiation and reporting to site management status of internal audit program. Lead and participate in internal audits
Provides mentorship to CAPA owners to ensure compliant and timely records through sound problem-solving practices and scientific methods
Perform/supervise investigations into product incident reports of internal & external events, with emphasis on use of root cause and/or other analysis tools and verify effectiveness of implemented corrective actions to prevent recurrence of adverse events
Lead Management Review meetings with Quality Management support, and develop Management Review presentation materials and meeting results/minutes
Support Quality System audits/inspections by external auditors; support FDA back room activities
Recommend process improvements and lead teams and initiatives to actively drive compliance and product/process quality
Provides support in general quality program issues to support Quality Department effectiveness
Continuous improvement experience a plus (6 Sigma, Lean, GreenBelt/Black Belt)
5-8 years of Quality System experience in the medical device industry; Experience with electro-mechanical devices in a design and manufacturing environment a plus
Lead Quality auditor, regulatory investigator, or equivalent status, and/or also with having performed internal process audits
Problem root cause analysis subject expert, verification & validation, flow mapping, and organizational and time-management skills
Computer proficiency with background in Agile and SAP business information systems a plus
Working knowledge of Medical Device Regulations and Standards (FDA, ISO 13485, ISO 14971, MDD, IVDD)
Energetic, results-driven with excellent organizational and prioritization skills
Excellent written and verbal communication skills and highly effective time management skills
Ability to operate independently and as part of a team
Commitment to continuous improvement principles

Senior Quality Systems Engineer Resume Examples & Samples

Evaluate quality system goals, identify process opportunities and apply scientific methods, statistics and problem solving techniques to improve and sustain process effectiveness
Manage and document configuration changes to the MasterControl Quality Management System
Serve as primary contact with MasterControl Technical Support to resolve technical issues
Develop, validate and deliver training on the MasterControl application and other Quality Management System processes
Initiate risk assessment for all proposed changes to MasterControl and operating environments
Work with client’s process owners to fully utilize MasterControl’s capabilities to enhance their processes
Learn, coordinate, and analyze databases associated with oversight of the Quality System and its reporting process
Support and perform internal and external audit activities, to include pre-audit planning, audit execution and evaluation and post-audit follow up and recommendations
Provide backup in reviewing and approving internal operating procedures
Assist with continued company certification to the appropriate Quality System Standards and Regulations, and assist with all related audits and inspections as required
Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to ISO quality systems and federal regulations

Senior Quality Systems Engineer Resume Examples & Samples

Leads teams to identify and analyze improvement opportunities; leads execution of such process improvement projects utilizing lean six sigma tools
Participates in development and deployment of effective, efficient, and harmonized Quality System
Assures implementation of harmonized Quality System process across facilities through training and participation
Executes changes to Quality System documents and SOPs utilizing change control process
A seasoned, experienced professional with a full understanding of quality systems engineering, resolves a wide range of issues in creative ways. Provides quality engineering support to quality systems/regulatory affairs functions and to assigned manufacturing location(s) as required, based on both in-process manufacturing and post-market quality analyses
Leads in the development, review, and improvement of manufacturer quality plans and manufacturing processes related to FMCNA products
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions
Normally receives little instruction on day-to-day work, general instructions on new assignments
Performs periodic audits of quality systems and raw material suppliers to ensure FMCNA and regulatory requirements are being maintained
Reviews process improvement recommendations and participates in planning and implementing manufacturing changes with the manufacturer
Performs trend analysis of quality data associated with FMCNA products and recommends corrective/preventive actions for problem resolution
Reviews new documents and changes to existing documents to ensure enhanced quality and productivity, while maintaining compliance with FMCNA Corporate and FDA requirements
Ensures quality systems are established and maintained in compliance with applicable local ordinances, state statutes, and Federal regulations, and other laws
May provide assistance to lower level staff with more complex tasks that require a higher level of understanding of functions
Mentors other staff as applicable
Monitors and prioritizes business need in order to complete and close all activities in a timely manner
Maintains knowledge of all processes and quality principles to assist with daily operations and continual improvement activities
Establishes personal quality improvement goals
Assists with various projects as assigned by a direct supervisor
Minimum 5 – 8 years of related quality systems engineering experience in a highly regulated industry; with a Master’s Degree 3 years of experience is acceptable. Experience within the areas of quality engineering, regulatory affairs, quality assurance management, change control, or configuration management desired
Certification in Six Sigma Black Belt, Lean Six Sigma, CQE
Proven expertise in lean six sigma tools and regulatory requirements (FDA/ISO)
Ability to understand and employ mathematics at an engineering or scientific level
Familiar with quality improvement tools and other various quality techniques
Strong technical report writing skills. Ability to read, analyze, and interpret common scientific and technical reports, technical procedures, or governmental regulations
Strong knowledge or aptitude to understand QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820, CFR 210/211, ICH Guidance, ISO 14971, and ISO 13485
Demonstrated understanding of product development lifecycles, design change, and document change control
Experience supporting FDA inspections or ISO audits preferred
Adept in use of computer software: MS Word, Excel, PowerPoint, statistical packages, web-based documentation systems
Experience with process verification and validation methodologies, manufacturing/production process control methodologies, and risk management and regulatory requirements related to the assessment of product and process changes
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, and in-depth understanding of FMCRTG site level products and related processes
Excellent oral communication, report, business correspondence, and procedure-writing skills
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, process controls, and/or document change controls

Senior Quality Systems Engineer Resume Examples & Samples

Independently audit/create/review/approve/release production Quality System documents/SOPs/work instructions as required, COs and Device History Records during device manufacturing, and communicate necessary changes to applicable department representatives to maintain compliance. Work with other departments to train and educate where necessary to ensure procedures are adequate
Support New Product Introduction projects as Quality Representative by performing the following activities: attend design & development team meetings; create/review/approve associated quality documentation [device master records, quality control plans, engineering/production risk analysis, labeling, engineering verification & validation results, production process validation results, and engineering change orders]; review design for quality improvements and manufacturing ease; support transfer of design to production; participate in pilot runs and review Process Failure Modes and Effects Analyses and provide feedback on effectiveness; ensure compliance to NPI procedures
Independently communicates within the project teams as well as Sr. Leadership through project reviews and status reports.Facilitates meaningful and constructive exchange of ideas and knowledge.Drives change in culture through ongoing training and education for project teams
Perform/supervise internal & external audits of applicable QSR/ISO processes and maintenance of applicable QSR databases to meet regulatory information tracking needs.Support Quality Team by addressing Audit Findings, Implementing CAPA, and updating Quality System documentation as needed
Perform/supervise investigations into product incident reports of internal (R&D, receiving, production, shipping) & external (customer complaints, service reports) adverse events, with emphasis on use of root cause and/or other analysis tools and verify effectiveness of implemented corrective actions to prevent recurrence of adverse events.Also, review internal and rework notifications/work orders to determine opportunities for corrective action. Includes review of Out of Box/Clean Instrument Failure metrics and implementing any associated corrective actions
Recommends process improvements and actively stays involved in the global development of processes and tools.Processes change orders to implement these improvements
Support insourcing projects as well as Continuous Improvement and LEAN projects as Quality Representative to ensure projects meet internal Quality requirements
Provides project direction and leadership in general quality program issues to support Quality Department effectiveness, in support of quality initiatives, and coordinate internal resources to ensure projects are complete and implemented on time. Recommend and implement enhancements to the Quality System that result in improved performance, increased customer satisfaction, and simplification of processes to reduce costs
BS (MS a plus) in Engineering and/or technical discipline, or equivalent, with minimum of five to eight years related experience and/or training; or equivalent combination of education and experience
Experience with scientific instrumentation in a design and manufacturing environment; in either a quality, regulatory, design, or manufacturing role; within a medical device related company; or equivalent

Senior Quality Systems Engineer Resume Examples & Samples

Act as the Supervisor over the site Corrective and Preventive Action (CAPA) department
Provide support to ensure robust and compliant CAPA records
Identify and lead initiatives to continuously improve the CAPA process
Support the Global CAPA function through participation in various projects
Act as site Subject Matter Expert during external and internal audits
Provide leadership role in championing departmental or cross-functional engineering initiatives
Provide project direction, coaching, and mentoring for engineering and technical team personnel
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Assure the development and execution of streamlined business systems which effectively identify and resolve quality issues
Actively participate and promote a work environment that supports the Quality Policy and Quality System
Bachelor Degree in the Engineering or Science field, plus 6-9 years of related experience or an equivalent combination of education and work experience
Robust understanding of Corrective and Preventive Action, Nonconforming Product regulations
Comprehensive understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
Comfortable speaking with and presenting to various levels of site and divisional leadership
Strong working knowledge of Microsoft Word, PowerPoint, and Excel
High level of attention to detail and compliance
Ability to effectively support multiple high priority deliverables at once
Creative and innovative thinking
Experience with Internal and External Audits
Past supervisory experience

Senior Quality Systems Engineer Resume Examples & Samples

Owns and executes assigned NCEPs and CAPAs
Mentors and provides direction to other owners of NCEPs/CAPAs
Provides support to ensure robust and compliant CAPA records
Understands and provides guidance on eCAPA system functionality
Supports collection and analysis of CAPA metrics as requested
Participates actively in initiatives to continuously improve the CAPA process
Supports/participates in Compliance and External Audit related initiatives
Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Actively promotes and participates in a work environment that supports the Boston Scientific Quality Policy and Quality System
Performs other Quality Systems duties as assigned
BS/BA degree with minimum 5-8 years of relevant experience OR MS with 3-6 years of relevant experience
Strong technical writing and communication skills
Strong process orientation when planning and performing work
Able to collaborate effectively
Able to develop and implement solutions to diverse business problems of medium to high complexity
Able to work independently with minimal direction and supervision
Ability to handle multiple projects simultaneously and to manage workload effectively
Proficiency with Microsoft Office Word, Excel, PowerPoint and Outlook
Experience owning nonconformance and CAPA records/knowledgeable about CAPA phases and associated requirements
Medical device industry experience
Hands-on experience with eCAPA system
Knowledge of and experience using problem solving tools, and capable of facilitating problem solving process
Aptitude to understand engineering and other technical information
Project management and time management skills
Experience leading small teams to achieve project goals
Working knowledge of, and effective interpretation and application of, medical device regulations and ISO requirements; e.g., 21 CFR 820, 210, 211 and 11; ISO 13485, and other applicable worldwide regulations

Senior Quality Systems Engineer Resume Examples & Samples

Conducts internal audit and drives effective closure of findings
Facilitates deployment and implementation of global specifications and GQS initiatives
Assists sites in maintaining their certifications
Provides training whenever necessary
Coordinates the implementation of good practices
Generates and maintains documents for effective process execution
Participates in activities that support the group and company objectives

Senior Quality Systems Engineer Resume Examples & Samples

Conducts internal or external audits as assigned to ensure compliance to company quality system requirements
Insures that full range of black belt tools are used when appropriate for product and process changes in Braintree plan, particularly new products
Leads product improvement projects and consults on supplier changes to ensure qualifications are met
Leads teams/projects related to Complaint investigation, CAPA, cost reduction, and quality system excellence. Use of TQM tools including Six Sigma is required
May lead design review of new platforms and assures that appropriate tests are performed to achieve sigma level expectations for quality
May maintain an active role in supplier and new business assessment and development
May manage and lead CAPA program, implementing global CAPA policies
Required to have specific product or process expertise to fit business needs

Senior Quality Systems Engineer Resume Examples & Samples

Bachelor’s degree from an accredited University
2+ years’ experience in a regulated industry
Keen understanding of international quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives

Senior Quality Systems Engineer Resume Examples & Samples

Minimum of Bachelors in a a technical field
Minimum of 5 years in a quality function in a medical device/IVD industry
Project management, design controls and validation experience a plus
Certified Quality Engineer or Auditor (CQE/CQA) preferred
Intermediate to advanced expertise of Microsoft Word, Excel, and Powerpoint

Senior Quality Systems Engineer Resume Examples & Samples

Contribute and maintain various other quality related activities as needed
Minimum Bachelor Degree in Electrical Engineering, Physics, Material Sciences, or Computer Science preferred, Masters Degree is a Plus
6+ years of direct Semiconductor Quality Management Systems and Reliability Experience
Lead auditor certification to TS16949 or TL9000 (preferred) or ISO9001:2008 (Minimum)
Experience in Automotive industry (PFMEA, Control Plan, PPAP)
Excellent communication (verbal & written), with very strong time - project management skills
Facilitate teamwork to effectively communicate and execute improvement activities across multiple engineering and business disciplines, geographies and time zones
Fundamental understanding of CAR/PAR (8D) methodology
Working Knowledge of ISO9001, TL9000, Quality management System standards, with direct audit experience & accreditation desired
Working knowledge of CMMI Standards, Implementation, and methodologies
ASQ Certification, Engineer, Auditor, SQE
Six Sigma Training or Certification is a plus
Quality Documentation, creation, process flow mapping/development, Project Planning, and implementation

Senior Quality Systems Engineer Resume Examples & Samples

Acting as a quality systems subject matter expert champions digital health/ hospital solutions process development and global continuous improvement activities while ensuring they meet regulatory requirements
Must have experience in CAPA – Corrective Action Preventive Action – owning and executing quality system changes
Must have good understanding of quality system and how each quality system element connects
Responsible for maintenance of Healthcare Solutions Quality Plan
Must have experience in working with vendors – understanding what services they are providing and how the service fits into the BSC quality system
Provide insight and expertise on quality system processes and to both internal BSC customers as well as working with external partners
Must be able to apply project management principles and techniques as they relate to quality system planning, implementation and tracking. Must be able to evaluate and manage risk
Facilitates bi-weekly Digital Health & Healthcare Solutions meetings driving actions to conclusion
Basic understanding of software validation methodologies is beneficial
Basic understanding of product development processes is beneficial
Bachelor Degree in the Engineering or Science field, plus 4-6 years of related experience or an equivalent combination of education and work experience
Experience with CAPA, Vendor Controls, and External Audits
Comfortable speaking and presenting to leadership
Creative thinking and innovation