Quality Engineering Manager (Billerica, MA)

As one of the world’s leading analytical instrumentation companies, Bruker covers a broad spectrum of advanced solutions in all fields of research and development. All our systems and instruments are designed to improve safety of products, accelerate time-to-market and support industries in successfully enhancing quality of life. We’ve been driving innovation in analytical instrumentation for 50 years now. Today, worldwide more than 6,000 employees are working on this permanent challenge, at over 70 locations on all continents.

Bruker Daltonics as an immediate need for a Quality Engineering Manager in our Billerica, MA headquarters. The Quality Engineering Manager is a hands-on functional leader who collaborates with engineering, marketing, sales, operations, and other functional groups to design, develop, implement, and manage the full battery of quality management systems, processes and procedures to ensure compliance to requisite regulatory requirements and to drive lean, effective quality management systems through the entire product life cycle. The ideal candidate is a self-motivated individual who thrives on a dynamic, fast-paced environment and being part of a highly-skilled technical team.

Responsibilities:

• Mentor, develop, and manage assigned direct reports
• Complete & deliver annual performance reviews
• Develop, implement, and manage Quality Management Systems processes and procedures which are compliant with the FDA QSR (21 CFR 820), ISO 13485, and ISO 9001
• Drive effective QMS processes from a Quality Engineering perspective with specific focus on Design Controls (21 CFR 820.30)
• Lead effective CAPA initiatives from concept through effectiveness verification
• Prepare technical test protocols and reports (e.g. Design Verification / Validation) which comply with 21 CFR 820.30
• Collaborate with engineering to qualify suppliers, components, etc.
• Lead QMS process improvement efforts and QMS lean initiatives

Qualifications:
• 10 years minimum experience in quality engineering discipline focusing on design controls; risk management; complaint handling; MDR reporting; CAPA; supplier quality management; and other industry-standard quality engineering functions.
• Bachelor’s degree in physics or engineering (electrical, mechanical, chemical, or biomedical; other technical disciplines may be considered)
• Extensive hands-on experience applying the FDA QSR (21 CFR 820) is mandatory.
• Extensive working experience at an OEM medical device manufacturing company is mandatory.

Please apply at http://www.bruker.com/about-us/career.html.

Bruker Corporation offers a comprehensive and competitive benefits package including medical, dental, 401(k), paid vacation, holidays, and tuition assistance (as applicable). Bruker is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics.