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Design Quality Assurance Specialist
2 months ago
Job Title: Design Quality Assurance Specialist
Job Summary:
Brilliance Cyber Systems INC is seeking a highly skilled Design Quality Assurance Specialist to join our team. As a Design Quality Assurance Specialist, you will be responsible for leading design quality assurance activities for post-market design changes on capital hardware.
Key Responsibilities:
- Lead design quality assurance activities for post-market design changes on capital hardware.
- Evaluate product issues to identify and assess patient user and security risks.
- Maintain and update Design FMEA (DFMEA) and Design History File (DHF) documents as part of the post-market design change management process.
- Provide comprehensive support to Post Market Development Teams focusing on design quality and risk management.
- Collaborate across departments to understand and analyze data to assess patient/user risk during the post-market phase.
- Manage complaint and severity trending and participate in signal disposition activities.
- Oversee the risk management file throughout the product life cycle ensuring it reflects the latest risk knowledge.
- Ensure compliance with organizational procedures regulatory requirements (QSR 21 CFR 820 EU MDD 93/42 EEC) and industry standards.
- Lead the timely completion of assigned corrective and preventive actions (CAPAs) and address audit findings.
- Analyze data to identify calculated risks and propose effective solutions.
- Assist with developing and implementing process validation procedures according to QSR FDA and international guidelines.
- Coordinate activities with the Quality Engineering Manager and report on progress regularly.
Qualifications:
- Minimum of 7 years of experience in Design Quality Engineering or a combination of an advanced degree and 5 years of relevant experience.
- Excellent written and verbal communication skills with a focus on technical writing.
- Proven experience in conducting risk assessments for manufacturing and/or electromechanical medical devices.
- Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC).
