The Sr. QE is responsible for supporting the development, implementation, and maintenance of quality systems to ensure compliance with EN ISO 13485:2016, CMDR (Canadian Medical Device Regulations), MDD (Medical Device Directive) and FDA QSR working closely with cross-functional departments
DUTIES & RESPONSIBILITIES
- Manage Corrective & Preventive Action (CAPA)/ Supplier Corrective Action (SCAR) System.
- Help facilitate Complaint/MDR System. Ensure complaint management activities are conducted in a proper and timely manner, including receipt from the field, investigation receipt and closure.
- Work collaboratively with other departments (e.g. R&D, Operations, etc.) on complaint event analyses.
- Conduct problem solving, root cause investigation, developing action plans, effectiveness checks activities.
- Help facilitate audits, internal and external. Issue CAPAs/Corrections resulting from such audits.
- Support supplier evaluation & monitoring activities. Coordinate supplier audits during initial qualification and re-evaluation, review the reports, follow-up issuing SCARs and ensuring SCARs are completed.
- Collaborate with R&D project teams to support and or process design and development activities.
- Provide comprehensive review of the Risk Management File, Design History File, Device Master Record and all other deliverables required for each phase per the Design Control system.
- Help facilitate Returned Goods Analysis (RGA) System.
- Help facilitate NCR and Deviation Systems.
- Initiate Engineering Change Orders (ECOs) as necessary. Review ECOs to ensure correct and complete and to detect any compliance issues.
- Other duties as required to support operation of the quality system.
- Knowledge of CAPA/SCAR system.
- Knowledge of trending and analysis of Quality Data.
- Coordinate or conduct Supplier Audits.
- Understands basic statistical data analysis.
- Proficiency with MS Word, MS Excel, and MS Visio.
- High level of attention to detail and organization.
- Proven ability to effectively work cross-functionally at all levels of the organization.
- Must be able to function in a typical startup environment (fast pace, multi-tasking, tight deadlines).
- Excellent verbal, written, and presentation communication skills.
- Understanding of Medical Device Risk management.
- Working knowledge of current EN ISO 13485:2016, CMDR (Canadian Medical Device Regulations), MDD (Medical Device Directive) and FDA QSR.
Preferred Education and/or Job experience:
- Bachelor’s degree in Engineering or related technical discipline
- 5+ years’ experience in a quality role in the medical device industry, preferably with a Class III medical device.
- Understanding of design controls, risk management, statistical techniques, complaints/MDRs, NCRs/MRB, Deviations, RGAs, CAPAs/SCARs, internal audits, and supplier audits.
- Preferred Certifications: ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), ASQ Certified Biomedical Auditor (CBA).