Staff Advanced Quality Engineer in Allendale, NJ at Stryker Corporation

Date Posted: 8/22/2019

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.

Charismatic networkers. Relationship-savvy people who intentionally make connections with both internal partners and external contacts.

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 a Staff Advanced Quality Engineer, you will act as a quality leader to collaborate with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects. You will lead risk management activities to ensure the highest level of product and process quality.

Responsibilities:

  • Develop quality assurance documentation to support new product development process and regulatory submissions.
  • Lead quality system maintenance by identifying and correcting deficiencies in procedures and practices.
  • Mentorship of quality engineering team members, technical ownership, development and improvement of quality processes.
  • Partner with cross-functional project teams to lead product and/or process design and development activities.
  • Lead risk management activities for new product development projects.
  • Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
  • Present risks associated with the product use during Design Reviews and track the design, documentation, and manufacturing process mitigate those issues throughout the development process.
  • Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
  • Partner with Advanced Operations in the development of manufacturing processes for new products.
  • 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.
  • Provide support and direction for other Quality Engineers.
  • Evaluate predicate products for relevant quality issues tthat 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.
  • Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
  • Lead investigation and health risk assessment for post-market events.

What you need

Basic Qualifications:

  • Bachelor's Degree in engineering or science related field
  • Minimum 5 years’ experience in engineering, quality, manufacturing, NPD or working in a highly regulated industry

Preferred Qualifications:

  • MS, CQE, or CRE preferred.
  • Six Sigma Green or Black belt preferred.
  • 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.
  • Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).

Work From Home: No

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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