Quality System Job Description
Quality system
provides rigorous assessment of quality system activities and documentation to assure compliance with policies and procedures, FDA regulations, ISO 13485, and Medical Device Requirements through the review of documents and records.
Quality System Duties & Responsibilities
To write an effective quality system job description, begin by listing detailed duties, responsibilities and expectations. We have included quality system job description templates that you can modify and use.
Sample responsibilities for this position include:
Establishes linkages to other key quality systems/programs like Design Controls, Technology Transfer, Production & Process Controls, External Manufacturing, Calibration, Preventive Maintenance
Linking Quality Systems (Oracle, Unisys, LIMS, Specifications, Shop Floor, ) to ensure customer quality requirements are understood, met and fully documented
Maintain Site Quality Management System (QMS) framework procedures ensuring agreed updates and amendments are implemented and controlled
Maintain process quality documentation, specifically process inspection schedules ensuring information is accurate and up to date
Facilitate updating and dispersal of all relevant quality information to the Production Stream and other functional areas as required
Analyse & Report Quality Performance Metrics /KPI's Generate trend analysis and management reports relating to quality data (Including Lab testing data) to facilitate the generation of KPI's and help drive continuous improvement
Maintain Site HACCP Plan Maintain the site HACCP plan and associated documentation
Develop and maintain a systematic approach to storage and retrieval of Quality Records - working with other functional areas to ensure consistent application
Receive and log complaints (ie Customer, Store, Careline), interface with VS on investigation and corrective action and provide a response to the complaint via the Careline or other authorised route
Facilitate Pest Control Facilitate the site's pest control programme, interface with VS on investigation and corrective action and keep pest control log up to date
Quality System Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality System
List any licenses or certifications required by the position: ISO, 9001, ASQ, QMS, CQE, CQA, LEAN, IRIS, AS9100, SUD
Education for Quality System
Typically a job would require a certain level of education.
Employers hiring for the quality system job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Education, Business, Associates, Chemistry, Management, Biology, Technology
Skills for Quality System
Desired skills for quality system include:
Quality systems
ISO 13485
Regulations for Medical Device Reporting
Strong performance management skills
Quality Systems Regulatory requirements and application to Company /Unit requirements
GMP
Decisions regarding reportability of complaints to FDA and other international regulatory agencies
ISO 13485 and Canadian Regulations
MDD
Microsoft excel
Desired experience for quality system includes:
Process user access requests and other routine system administration requests in a timely matter
Manage and respond to System Administration Help Desk Tickets in order of receipt and priority, using system knowledge of MasterControl, independent troubleshooting experience, knowledge of the documentation process and connecting processes such as the training process
Review the test requests and reports, site generated records for calibration preventative maintenance, deviations, non-conformances, Corrective and Preventative actions and local work instructions
Support audits affecting the site including internal audits, audits conducted by other Johnson and Johnson groups and support requests for data by external authority’s or other Johnson and Johnson groups
Assist in the upkeep of site SharePoint and websites
Assist the site Sterilization and Microbiology testing execution team in the development of quality compliance and lean processes to meet customer needs
Quality System Examples
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Quality System Job Description
Job Description Example
Our company is looking for a quality system. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality system
- Be a business partner to Operations ensuring the Quality Management team drives leadership in both compliance systems and management proactively working with the leadership at each site to drive continuous improvement to ensure on time delivery and quality
- Maintains, enforces, and manages a compliant and effective QMS for the activities in scope, for effective and lean QMS structures and documents for Q&R processes at all levels
- Maintain problem solving log, monitor the responses, and audit countermeasures
- Maintain gauge calibration schedule
- Author and gain approval for high quality application validation documents which are compliant with PHPR0210, Validation Planning Procedure, and associated documents
- Review and provide input on technical specification validation documents to ensure the system design will meet our customer’s requirements and objectives
- Coordinate and support the deployment of new functionality to current users
- Draft, submit for approval and monitor change requests needed to support compliance to regulatory standards and to improve business processing
- Develop, maintain and deliver software application training content which is instructive, easy to follow and value-added for our customers
- Lead the application Key User Groups to provide a forum for communication on issues and status, best practice sharing, and change request identification and prioritization
Qualifications for quality system
- Clinical Laboratory Scientist (Medical Technologist) CLS License is strongly preferred
- Bachelor of Science Degree in Biology or related science preferred
- Minimum of 1 year experience in complaint handling management
- Advanced skills in MS applications (Word, Excel, PowerPoint, Visio, and Project) are preferred
- Experience with SAP, TrackWise and/or Minitab is preferred
- Experience within a diagnostics, life sciences, or medical device environment preferred
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Quality System Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of quality system. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality system
- To build capability of entire team on Quality systems & processes through regular classroom on job training
- Provide efficient and effective email and website communication to our customers concerning topics such as application status, changes and training
- Report out on the performance of Q&R tool applications per the Application Health Reports
- Utilize the IT ticket management system (SNOW or other) to enter, monitor and escalate, when necessary, application issues
- Identify, develop and implement queries and reports which require administrative permissions or a high degree of system knowledge which cannot be transferred easily to our customer
- Manage the process of the complaint handling system including, receipt of complaints from all sources and all in process steps including data entry
- Provide training to personnel involved in overall complaint process as directed by management
- Participates in all training classes including but not limited to, product training, regulatory training, compliance training and any testing involved
- Maintains annually competencies through training and documentation of training
- Contact the customer or vendor for further information or follow up
Qualifications for quality system
- Knowledge of industry specific quality standards and regulations, AS9100, ISO9001, AS5553, AS9120, CMMI
- Minimum 1 year Nursing or Medical Technologist experience or equivalent Medical Device Reporting experience
- Must have knowledge of product failure modes
- Must have working skills in addition to product knowledge of product usage & ability to differentiate between significant and non-significant health risk to patient and or clinician
- Preferred Licensed Medical Professional desired such as Associates or Bachelor’s Registered Nurse (RN) and/or Associates or Bachelor’s Med Technologist
- 3+ years of industry experience in product development within high-tech
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Quality System Job Description
Job Description Example
Our innovative and growing company is hiring for a quality system. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality system
- Sample routing when applicable, to the investigation site
- May interact with Health Care Workers, consumers, public and other professionals regarding their Quality concerns
- Assist in maintaining customer relations via multiple means, written, verbal
- Review of complaint prior to closure for accuracy and follow up acknowledgement notice, if required
- Ensure that the customer compliant complies with all relevant procedures
- Remain current in product knowledge and any upgrades to complaint handling systems
- Review closing letters for accuracy and to ensure right the first time approach to customer communications
- Maintain expert knowledge level of the Trackwise compliant handling system
- Provide feedback to management for Trackwise / compliant process improvement opportunities
- Provide training to peers as requested by management
Qualifications for quality system
- Working knowledge of MS Office S/W suite (Word, Excel, Outlook)
- Evaluation of existing Quality System processes across NIBR for the identification of potential gaps to Novartis and regulatory requirements
- Monitoring the performance of the Quality Management System
- 10+ years broad experience in a scientific/pharmaceutical/biotech industry
- Basic qualification - Bachelor's Degree in Computer Science, Science or a related technical degree * Possess statistical data analysis and data system automation skills
- Analytical skills with a Bifocal approach - ability to zoom-in/zoom-out for tactical, high-level and detailed
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Quality System Job Description
Job Description Example
Our growing company is hiring for a quality system. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality system
- Provide back up for the US data analyst
- Run RCC local compliant metrics reports as needed
- Triage customer escalations and escalate to the business units for response and resolution as needed (non-IDN customers)
- Perform history check on previously submitted complaints by customer to ensure that the customer is receiving an appropriate closing response
- Review customer letters to ensure accuracy and appropriateness of the letter content
- Provide feedback to complaint leadership and complaints team regarding letter content and provide guidance for improvements
- Contact the customer as needed to provide updates to outstanding quality issues
- Develop & document site Quality manual
- Documentation of Global Quality standards & conduct internal audit program to assess effectiveness of Quality standards at site
- Document CAPA for all NCRs at site & close the same in coordination with site leadership team
Qualifications for quality system
- BS Engineering or Scientific discipline
- Keen understanding of FDA regulations
- Prior exposure to Biologics and/or blood products
- Bachelor's degree in Engineering or Business, with emphasis upon Operations or Engineering Management (MBA or MS preferred)
- Extensive experience (7 plus years) with at least 5 years of experience in quality management in a manufacturing environment
- 8+ years experience with Quality Assurance programs in a PCBA manufacturing environment preferred, especially in QMS area
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Quality System Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality system. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality system
- Performance and Development Planning and Evaluations for Quality Systems Team Members
- Provides continuous support and mentoring to Quality Systems Specialists and Department members
- Ensure compliance to Quality plan of the site & communicate effectively to leadership team
- To manage entire online CRS process & communicate results after detail analysis of customer / consumer complaints
- Monitor shop floor quality KPIs & ensure all products should meet all KRAs before release to market
- Monitoring process capability of entire process & use CAPA as a part of continuous improvement plan
- Pursues efficient development paths and opportunities to drive speed to market
- Ensures new TB product bundles achieve target cost, and works to identify ongoing margin improvement opportunities
- Advocates and drives product, materials, process, and package standardization and simplification
- Coordinates TB bundles development activities across all functions
Qualifications for quality system
- Demonstrated ability to work independently, take initiative, complete complex tasks to deadlines
- Strong communication skill with leadership abilities
- High Mix - Low volume manufacturing environment experience advantageous
- PCBA and Mechanical Box Build manufacturing environment experience advantageous
- Quality related certifications advantageous (ISO Internal auditor certification)
- FDA 21 CFR part 820 knowledge