Quality Manager - Design Quality Engineering

Job Title Quality Manager – Design Quality Engineering Design Quality Manager In this role you will lead a team of Design Quality Engineers, providing guidance to project teams both as a manager and as a subject matter expert regarding design controls, regulations, and internal processes. Your role Lead a team of Design Quality Engineers regarding design controls, regulations, and internal processes. Act as a “Super User” in the interpretation of the design controls process outside of specific projects as they apply to business needs. Support engineering development teams throughout the development lifecycle to ensure robustness in the design. Lead your team and work with others to develop and apply advanced statistical tools to measure and metric develops to support EU‑MDR Part 88, other forms of trending analysis for rare events, and product reliability modeling. Perform post‑market risk assessment to determine the effect of product defects on field residual risk and assess against the company safety policy for acceptability/unacceptability; present this to MT level councils for review and approval. Facilitate design failure modes and effects analysis (FMEA) for diverse engineering teams involving software and hardware from system level to unit level. You're the right fit if Bachelor’s or Master’s degree in mechanical engineering, industrial engineering, science, or equivalent. ASQ CQE, CRE, CQM or related certifications are a plus. 5+ years of relevant experience, including demonstrated leadership and people‑management skill set. Strong mastery of quality principles such as the structure and topic areas of a quality system, CAPA, reliability, root‑cause investigation concepts and tools. Ability to teach, mentor and provide expert application of design quality concepts and tools such as verification vs. validation, requirements development and decomposition vs. specification development, safety risk management and FMEA. Preferred experience with EU‑MDR, 21CFR820, ISO 13485, ISO 14971/TS 24971, IEC 60601, IEC 62366, IEC 62304, IEC 60812/VDA FMEA Handbook. Must be able to successfully perform the minimum physical, cognitive, and environmental job requirements for this office/remote position. How we work together For on‑site roles, full‑time presence in the company’s facilities is required. This position is office‑based and requires in‑person attendance at least three days per week. Remote work is not an option. Pay and Benefits Compensation range is $134,000 to $186,000 annually, varying by location. Employees may be eligible for annual incentive bonuses, sales commission, and long‑term incentives. Benefits include generous PTO, 401(k) with up to 7% match, HSA with company contribution, stock purchase plan, and education reimbursement. Additional Information US work authorization is a precondition of employment. The company will not consider candidates requiring sponsorship for a work‑authorised visa, now or in the future. Company relocation benefits will not be provided for this position. Candidates must reside or commute to Cambridge, MA; Bothell, WA; Reedsville, PA; Plymouth, MN; or San Diego, CA. Equal Employment Opportunity Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace. #J-18808-Ljbffr Philips North America