Quality Engineer Product Safety/Compliance

Job TitleQuality Engineer Product Safety/Compliance

Job Description

The Quality Engineer Product Safety/Compliance ensures the safety/compliance of products and services and their compliance to all applicable safety/compliance laws, standards and regulations, before product launch and during the full product lifecycle.

Your role:

• Responsible for the structured analysis of product safety/compliance incidents in the market (including initiating follow-up) and ensures remediation
• Ensures BG/local commitment to product safety/compliance, and signs off declarations on product safety/compliance and compliance on behalf of BG/site management, reports and discusses trends in product roadmaps with Regulatory Affairs and Standards team that may require pro-active lobbying , building up of knowledge about new requirements and/or new relationships with authorities and/or certification bodies
• Leads all product safety/compliance related activities in the BG/Site to ensure that the regulations and policies are fully and 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
• Ensures proper root cause analysis 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 and validate designs regarding these requirements
• Makes and/or validates independent product safety risk assessments in line with conflict of interest rules and Philips & regulatory standards

You're the right fit if:

• You have acquired 3+ years of relevant working experience in a medical device or non-regulated industry and have working knowledge of appropriate global regulations, requirements, and standards.

• You have experience independently producing and completing safety and compliance engineering documents, assessing safety and compliance plans and design, reviewing test and other performance data analysis market feedback, and leading root cause analysis of safety and compliance problem solving.

• Your skills include a good understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements.

• You have a bachelor’s degree in engineering, or equivalent.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. 

• You’re an advisor to subordinates to meet schedules and/or solve safety/compliant/regulatory problems, developing and administering schedules, and performance requirements. Frequently interacts with subordinate supervisors and functional peer groups to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules

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 onsite role based in Cambridge, MA. 

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 $89,376 to $153,216

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.

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.