Senior Quality Engineer - Post Market Surveillance

Company: Stryker Group
Location: Shirley
Posted on: February 23, 2021

Job Description:

Senior Quality Engineer - Post Market Surveillance

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to develop products.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices. What you will do Stryker is looking for a person with a passion for partnering with our customers to create the best surgical outcomes with patient safety at the forefront. This individual will lead complaint investigations for the Airo Mobile CT Scanner. Within this role you will work within cross-functional internal and external teams to investigate product and process complaints, provide solutions to resolve complaints, and drive future best practices. Specific Duties Include:
  • Improve product quality, reliability and customer satisfaction by investigating product field failures and conducting trend analysis
  • Ensure timely, accurate, and complete failure investigations and root cause analyses through the use of QA tools (Root cause analyses, 4-D, 5 Whys, etc.) and document findings in TrackWise
  • Organize/lead cross-functional teams to help identify problem issue and drive product improvement
  • Deploy good design and manufacturing practices knowledge to make recommendations to prevent future failures
  • Support the resolution of field issues and work with R&D, Advanced Quality Engineering, and Operations in Quality, Product Development and Manufacturing to resolve issues
  • Ensure timely, accurate and complete failure investigations of product complaints leading to root cause and corrective/preventive action
  • Lead product family complaint reviews by presenting complaint trends and recommendations for corrective action and product improvement
  • Work with Advanced Quality Engineers to complete Post-Market health risk assessments
  • Other duties as assigned What you need
    • Bachelor's Degree in Engineering or related - Electrical or Software area highly preferred.
    • Minimum of 3 years of experience as a Post Market Quality relevant role conducting failure investigations and/or performing failure analysis highly preferred
    • Demonstrated applied knowledge Advanced Quality tools such as Top-Down Risk Assessment, Failure Modes Effect Analysis (FMEA), SPC, Root Cause Analysis, Mistake Proofing/Poka Yoke highly preferred Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Keywords: Stryker Group, Stamford , Senior Quality Engineer - Post Market Surveillance, Engineering , Shirley, Connecticut