Senior Quality Engineer Product Safety & Compliance

Job Title

Job Description

The Senior Quality Engineer Product Safety/Compliance is a key member of the Sleep & Respiratory care (S&RC) Patient Safety and Quality organization, responsible for ensuring the safety/compliance of products and services to all applicable safety/compliance laws, standards and regulations, before product launch and during the full product lifecycle.

Your role:

• Leads all product safety/compliance related activities in the Business Group/Site to ensure that the regulations and policies are fully/timely available and interpreted, products comply with all regulatory requirements and Philips policies and incidents are handled according to corresponding product safety/compliance incident handling process, including review and decision making on product safety/compliance related escalations.
• Responsible for the structured analysis of product safety/compliance incidents in the market (including initiating follow-up) and ensures remediation. Ensures Business Group/local commitment to product safety/compliance, and signs off declarations on product safety/compliance and compliance on behalf of BG/site management
• Ensures proper root cause analysis (RCA) in case of product safety/compliance non compliances according to regulations and/or the 8D methodology; proper reflection of all relevant regulatory requirements in all projects, OEM/ODM products, including lifecycle management and verify/validate designs regarding these requirements. Makes and/or validates independent product safety risk assessments (ISO 14971) in line with conflict-of-interest rules and Philips & regulatory standards
• Reports on and discusses trends in product roadmaps with the Regulatory Affairs and Standards team that may require proactive negotiation, expanding knowledge of new requirements and/or building new relationships with authorities and/or certification bodies.

You're the right fit if:

• You’ve acquired a minimum of 7 years’ experience in Quality Engineering, focused on leading safety and compliance activities, including designing/overseeing the execution of safety and compliance plans, and complex designs, reviewing test and other complex performance/complaint data, analyses market feedback, and lead complete root cause analysis and complex safety and compliance problem solving in global FDA regulated medical device environments.
• Your skills include detailed knowledge/ understanding of the Quality System/Product Regulations, requirements, and standards (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements.
• Your skills include detailed knowledge/ understanding of the Quality System/Product Regulations, requirements, and standards (ISO 13485, 21 CFR Part 803, 806 & 820, ISO 9001) and knowledge of medical device process requirements. You have proven experience/expertise with medical device design controls, product risk files, risk assessment and risk management (ISO 14971). Must have technical aptitude to understand designs and interpret how a design defect impacts patient safety.
• You have a minimum of a Bachelor’s Degree (Required) in Engineering, Quality or related disciplines, Master’s Degree desired. ASQ certifications-Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), and/or DfSS Green Belt/Black Belt preferred.detailed knowledge in medical device design controls
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this 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.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our commitment to diversity and inclusion.

Philips Transparency Details:

• The pay range for this position in Cambridge, MA is $116,000 to $200,000.

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 here. 

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.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.  Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.