Philips Quality Engineer- Products Systems 

United States, Massachusetts, Cambridge 

184141784

The Quality Engineer-Products and Systems is a key member of our Sleep & Respiratory Care, Quality organization, accountable for ensuring our Sleep & Respiratory Care products are safe and compliant with Internal/External regulations, requirements and standards

Your role:

• Ensures that appropriate Quality, Reliability‐and Post Market Surveillance (PMS) plans are made and include all stages of the product life cycle
• Supports Quality Plan design for hardware and Software design and ensure they meet quality and compliance standards for every planned milestone. Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
• Provides effective oversight of the execution of the quality, reliability, PMS Plans, any Risk Management activities, and all of design related activities during the product/system lifecycle.
• Performs independent technical assessment on product quality performance and post‐market product quality analysis to lead quality related problem solving and root cause analysis during design and manufacturing and initiates field actions when required.
• Supports stakeholders during the execution of quality system‐and product audits and inspections. Provide quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies.

You're the right fit if:

• You have a minimum of 3+ years’ experience of Quality Engineering experience within FDA regulated, medical device product environments, with a focus in Design Quality/Control, working knowledge of Risk Management (ISO 14971) and global medical device product regulations, requirements and standards.
• You have experience independently producing and completing quality engineering documents, performing timely quality engineering tasks including assessing quality plans, assessing product designs and reviewing test and other performance data, analyzing market feedback, and leading root cause analysis and quality 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 minimum of a Bachelor’s Degree (Required) in Engineering, Quality or related disciplines. ASQ certifications-Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), and/or DfSS Green Belt/Black Belt preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

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 of healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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Philips Transparency Details:

• The pay range for this position in Cambridge, MA is $97,440 to $155,904.

• 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 role may require travel up to 10%.