Quality Manager - Design Quality Engineering

Quality Manager - Design Quality Engineering In this role you Will Lead a team of Design Quality Engineers in providing guidance to project teams both as a manager and as a Subject Matter Expert to Core Teams regarding Design Controls, related regulations and the internal processes. Your role: Leading a team of Design Quality Engineers regarding Design Controls, related regulations and the 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 in the organization 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. Must be able to present this to MT level Councils for review and approval. Facilitate Design Failure Modes 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 / 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 in the field 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, etc. 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. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an office role. Philips Transparency Details The pay range for this position in Cambridge, MA is $134,000 to $186,000 Annually. The pay range for this position in Bothell, WA is $134,000 to $186,000 Annually. The pay range for this position in Reedsville, PA is $120,000 to $170,000 Annually. The pay range for this position in Plymouth, MN is $126,000 to $175,000 Annually. The pay range for this position in San Diego, CA is $134,000 to $186,000 Annually. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Cambridge MA, Bothell WA, Reedsville PA, Plymouth MN, San Diego CA. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. #J-18808-Ljbffr Mass Digital Health