Senior Design Quality Engineer
About The Position
Senior Design Quality Assurance Engineer In this role you The Senior Design Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle. The Senior Design Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The Senior Design Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes.
Requirements
- Bachelor's/Master's Degree Engineering or equivalent
- 5+ years of experience in Product development, Design Quality, Risk Management for medical device.
- Knowledge of 13485 / 9001 / FDA / Canada / 14971/ standards
- FMEA/ Root Cause Analysis/ Problem solving
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
Responsibilities
- Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
- 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 Plan , any Risk Management activities, and of all design related activities during the product/system lifecycle
- Performs independent technical assessment on product quality performance and post-market product quality analysis
- Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
