Senior Quality Engineer, Quality Engineering

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

An experienced Quality Engineering position at Walpole, which is involved in developing, implementing, maintaining, and improving systems to ensure products are designed and produced to meet or exceed customer requirements and expectations. The candidate ensures consistent implementation and compliance to the Siemens Healthcare Diagnostics Quality System and external regulations including, but not limited to, the FDA Quality System Regulation (21 CFR Part 820), ISO 13485 and In-Vitro Diagnostics Directive (IVDD).

In the Walpole location, the QE’s responsibilities include providing Quality Engineering support for Design Transfer, Design Changes, Change Control, Process Validation, and Risk Management processes. Key functions of the QE role include:

• Serving as the quality representative on the element team during the technical transfer from design to manufacturing.
• Supporting ongoing product and process changes post-manufacturing.
• Providing leadership in design control, process validation, and risk management within a Class II and Class III IVD reagent manufacturing facility.
• The Quality Engineer (QE) provides independent oversight and review of project deliverables throughout the lifecycle. They actively participate in the change management process to ensure products continue to meet customer requirements and collaborate as part of a cross-functional team alongside business and engineering disciplines.
• The QE reports to the Senior Quality Engineering Manager.

Required Knowledge/Skills, Education, and Experience:

• BS in Life Science or Engineering discipline with a minimum of 5 years of experience in the medical device, pharmaceutical or biotechnology industry.
• Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Process Validation and Design Controls; ISO 13485; and ISO14971.
• Proven experience providing quality engineering leadership to project teams in the areas of Design Controls, Process Validation and Control, and Risk Management.

Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The annual base pay for this position is:

Min $99,700 - Max $149,500

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelate