Senior CAPA Specialist in Salt Lake City, UT at Stryker Corporation

Date Posted: 11/10/2020

Job Snapshot

Job Description

Who we want

  • 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
  • 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

As a Senior CAPA Specialist you will be responsible for the oversight of the CAPA process and procedures at the Salt Lake City facility. You will mentor CAPA owners in problem solving methodology and facilitate proactive and effective resolution of issues. As a Senior CAPA Specialist you will ensure compliance to CAPA processes creating well-defined procedures and success cross functionally.

  • You will be responsible for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity and timeliness. Review & Approval of CAPA changes including extension requests.                                                                                                           
  • You will ensure users provide correct content and documentation within TrackWise eCAPA system, including maintaining a live document with all relevant evidence attached, in a timely manner.
  • As Problem Solving Methodology expert you will facilitate and coach NC & CAPA teams in the application of problem-solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc.
  • You will lead & execute the NC/CAPA Review board forums. Lead multi-site forums and participate in global forums.                                        
  • You will manage & monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums.
  • You will ensure adequate training is developed, maintained and provided to all users of CAPA process and systems                     
  • You will lead &/or participate in cross-plant and corporate project teams in areas of CAPA and quality systems improvement.

What you need

  • Bachelors in a Science, Engineering or related discipline
  • 2+ years of experience working in a regulated industry required (Medical Device Manufacturing is strongly preferred)
  • Experience owning CAPA records highly preferred
  • Experience utilizing Problem Solving and/or Continuous Improvement tools or training certification in the tools (e.g., Six Sigma, Lean Manufacturing, 8D, etc) highly preferred

Work From Home: Occasional

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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