Quality Engineer- Products and Systems

Quality Engineer – Products and Systems

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

• Ensure that appropriate quality, reliability‑and post‑market surveillance (PMS) plans are made and include all stages of the product life cycle.
• Support quality plan design for hardware and software design and ensure they meet quality and compliance standards for every planned milestone. Validate key design inputs such as usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
• Provide effective oversight of the execution of the quality, reliability, PMS plans, any risk management activities, and all design‑related activities during the product/system lifecycle.
• Perform 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 initiate field actions when required.
• Support 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.

• Minimum of 3+ years’ experience of quality engineering 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.
• 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.
• Good understanding of the quality system regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements.
• Minimum 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.
• Must be able to successfully perform the following minimum physical, cognitive and environmental job requirements with or without accommodation for this position.

Cambridge, MA. The pay range for this position is $97,440 to $155,904. The actual base pay offered may vary.

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 are not provided for this position. This role may require travel up to 10%.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.