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Job Title Senior Design Quality Engineer
Job Description If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may c ontact 888-367-7223, option 5, for assistance. Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.But it's not just what we do, it's who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers' needs. It's what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs. In this role, you have the opportunity to make life better Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.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. You are responsible for- 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
- Can Lead quality related problem solving and root cause analysis during design and manufacturing
- 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
- Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
- Independently Produces and completes Quality Engineering Documents.
- Responsible for performing timely, quality engineering tasks like: Assessing quality plans, assessing product designs and reviewing test and other performance data, analyses market feedback, lead root cause analysis and quality problem solving.
- May also provide other quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies.
- Bachelor's degree in engineering
- 5+ years of quality engineering experience
- Expertise in applying ISO 13485, ISO 14971, IEC 60601 and working knowledge with IEC 62304 and other relevant medical device standards
- Ability to collaborate and team with other functional groups.
- Highly motivated hands-on engineer with a proven record of meeting timelines and goals
- Must possess strong analytical & problem-solving skills
- Statistical software solutions such as JMP or Minitab
- ASQ CQE preferred
- ID: #21955478
- State: Pennsylvania Pittsburgh 15289 Pittsburgh USA
- City: Pittsburgh
- Salary: USD TBD TBD
- Job type: Permanent
- Showed: 2021-10-31
- Deadline: 2021-12-28
- Category: Architect/engineer/CAD