Sr Quality Engineer
Medical Device Product Development
Baltimore, MD

Global leader in the development of medical devices seeking a Sr. QA Engineer for its R&D facility. It is the responsibility of the Senior Quality Engineer to provide expert guidance on product design and processes as they relate to compliance with quality system requirements.

1. Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities.
2. Qualify suppliers and monitor their performance.
3. Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions and complaint investigations.
4. Proactively investigate, identify and implement best in class quality engineering practices
5. Provide training and support for quality system processes and quality engineering practices.
6. Identify and support effective process controls to support the qualification and on-going manufacturing of products.
7. Write, facilitate, execute and review complex validations independently and efficiently (including validations over many product codes, multiple assembly lines, to appropriate degree of confidence in keeping with procedures).
8. Participate in internal and external quality audits.
9. Suggest and lead system-wide quality based initiatives involving multiple departments.
10. Assess and recommend quality requirements for new products and acquisitions.
REQUIREMENTS:
1.Ten years of related experience in medical device industry/quality engineering role.
2. Typically requires one year of auditor experience
3. Knowledge of computer use
4. Strong writing skills and mathematics including statistics
5. Communication skills, both verbal and written
6. Organizational skills as well as time management skills essential for project work.
7. Typically is certified as a CQA or CQE and member of the ASQ
8. 4 year technical degree.

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