Advanced Quality Engineer in Allendale, NJ at Stryker Corporation

Date Posted: 10/31/2020

Job Snapshot

Job Description

Who we want

  • Patient-oriented achievers. Engineers with an unparalleled work ethic and customer-focused attitude who bring value to their partnerships.
  • Challengers & Influencers.  People who constantly challenge themselves and each other to achieve more & to win the right way.
  • Teammates.  Partners who listen to ideas, share thoughts and work together to move the business forward.

What you will do:
As an Advanced Quality Engineer you will lead Quality Engineering activities in the development of products to ensure the highest level of product and process quality.  You will provide guidance to the New Product Development teams to ensure compliance to the company's quality system and external standards

  • Develop quality assurance documentation to support new product development process and regulatory submissions.
  • Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices.
  • Engage in the design, development, manufacturing, and risk management activities for new product development projects.
  • Support risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
  • Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
  • Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
  • Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
  • Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc. 
  • Develop, review, and approve inspection plans, routers, and product drawings for new products. 
  • Support product design transfers to internal and/or external manufacturing facilities.
    Evaluate predicate products for relevant quality issues that may impact new product development projects. 
  • Analyze and define critical quality attributes for product and process through risk analysis techniques.
  • Participate in collection of initial market feedback on new products and address early concerns. 
  • Engage in the evaluation of overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership. Analyze and define critical quality attributes for product and process through risk analysis techniques.
  • Participate in collection of initial market feedback on new products and address early concerns. 
  • Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
  • Lead investigation and health risk assessment for post-market events.

What you need

  • BS in a science, engineering or related discipline
  • 0 + years’ experience in Quality Management Systems

Preferred Qualifications

  • Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
  • Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
  • Demonstrated ability to read and interpret CAD drawings.
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required. 
  • Thorough knowledge and understanding of US and International Medical Device Regulations.
  • Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
  • Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.

     

Work From Home: Not available

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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