Quality Engineer (Operations) - 30663BR - EN in East Whiteland Township, PA at Stryker Corporation

Date Posted: 5/25/2018

Job Snapshot

Job Description


As an Engineer, Advanced Quality you will lead engineering activities in the development of orthopedic implants and instruments to ensure the highest level of product and process quality. You will also be responsible for providing guidance to the New Product Development teams to ensure compliance to the company’s quality system and external standards.
  • You will develop quality assurance documentation to support regulatory submissions
  • You will additionally evaluate product design changes for verification and validation requirements and assist in change implementation.
  • In additional you will work with complaint investigators to complete post-market health risk assessments
  • You will support quality system maintenance primarily for the design control process by identifying and correcting deficiencies in our procedures and practices
  • You will lead and/or assist in resolving nonconformities and corrective/preventive actions (CAPA)
Implant-Specific Essential Duties and Responsibilities:
  • Support design, development and manufacturing of low volume customer-specific instruments and implants
  • Lead Risk Management activities for low volume customer-specific instruments and implants
  • Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation and manufacturing process mitigate of those issues throughout the development process for customer-specific instruments and implants
  • Support Product Development in the definition of design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria for customer-specific instruments and implants
  • Develop, review and approve inspection plans, routers and product drawings for customer-specific instruments and implants
  • Support product design transfers to internal and/or external manufacturing facilities for customer-specific instruments and implants
Robotic-Specific Essential Duties and Responsibilities:
  • Support design, development and manufacturing of robotic systems, software and instruments.
  • Develops Quality Assurance Plans for new products.
  • Lead risk management activities for robotics by developing risk management plans/reports, conducting risk reviews, verifying implementation and effectiveness of risk controls and driving post market activities.
  • Participate in design reviews by identifying design weaknesses and risks associated with the product use and tracking the mitigation of those issues throughout the development process.
  • Partner with engineering to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria. Promote efficient testing practices.
  • Complete or contribute to the completion of final design verification and design validation test reports by providing clear concise conclusions with statistical validity and graphical support when necessary.
  • Utilize standard statistical analysis and problem solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
  • Identify supplier assessment requirements and communicate these to the supplier quality group.

Job Requirements

  • Bachelor’s Degree in Engineering or related field of study.
  • CQE certification and Six Sigma Green or Black Belt preferred
  • 1-3 years of experience as a Quality Engineer (QE) in a regulated design environment.
  • Experience with medical device product development life cycle, including risk management and design/ process verification & validation is preferred
  • Demonstrated knowledge of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971
  • Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poka Yoke.
  • Demonstrated ability to read and interpret CAD drawings
  • Demonstrated ability to advocate product excellence and quality
  • Demonstrated ability to effectively communicate and work cross functionally with other departments including Advanced Operations, Product Development, Regulatory and Marketing.
  • Computer proficiency with Mini-tab or similar analysis program, Visio, MS Office.​

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