Senior Quality Engineer Role Summary:
The successful candidate will provide quality support during in-house manufacture and lot release, develop quality plans, programs and procedures for commercialization, ensure all work is carried out in compliance with quality, regulatory and company policies and systems, and review, analyze and report on quality discrepancies related to product design and manufacture.
Key Responsibilities:
* Provide quality support during in-house manufacture and lot release
* Develop quality plans, programs and procedures for commercialization
* Ensure all work is carried out in compliance with quality, regulatory and company policies and systems
* Review, analyze and report on quality discrepancies related to product design and manufacture
* Liaise and support OEM contractors/vendors during the manufacture of components
* Support during regulatory agency audits including FDA and Notified Body and aid in the preparation of non-conformity responses as necessary
Required Skills and Qualifications:
* Bachelor's degree in a relevant engineering or science field
* 5 years experience in medical device industry or equivalent higher-level postgraduate study (masters or PhD)
* Project planning, communication and writing skills
* Sound understanding of engineering fundamentals
* Knowledge of medical device quality & regulatory systems and medical device directives (ISO 13485 and FDA CFR 820) essential
* Cleanroom and sterilization experience preferred
* Process validation experience preferred