Philips Senior Quality Engineer- Products & Systems 

South Africa, Free State, Dihlabeng Local Municipality 

164024920

Senior Quality Engineer- Products & Systems
Job Description

The Senior Quality Engineer- Products and Systems is a key member of the Sleep & Respiratory Care (S&RC) Patient Safety and Quality organization, accountable for quality oversight of system, hardware and risk management throughout the product life cycle.

Your role:

• Provides independent oversight of the design input process, design V&V activities, design transfer/product realization, and performance in the field to ensure that all design requirements are effectively met. Also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes.
• Ensures that appropriate quality, reliability‐and Post Market Surveillance (PMS) plans are made; to include all stages of the product life cycle and 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’ve acquired a minimum of 7 years’ experience, to include leading quality engineering activities, including designing/overseeing the execution of Quality Plans, assessing complex product designs, reviewing test and other complex performance data, analyzing market feedback, and leading complex root cause analysis and complex 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 extensive experience and expertise with medical device design controls, product risk files, risk assessment and risk management (ISO 14971). Technical aptitude to understand designs and interpret how a design defect impacts patient safety a must.
• 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.
• 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. 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 $116,000 to $200,000.

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.