Design Quality Engineer

Role: Design Quality Engineer

Location: North Haven CT (Onsite)

Duration: Full Time/Permanent



Job Description:

Responsibilities:


Lead Design Quality Engineer for postmarket 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 postmarket 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 postmarket 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).

QSR,Medical Devices,Design Failure Mode and Effect Analysis (DFMEA),Design History,CAPAs