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Staff Specialist, CAPA

Company: Stryker Corporation
Location: Flower Mound
Posted on: June 12, 2021

Job Description:

About Stryker

Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

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 and expectations.

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

The Staff Specialist, CAPA will be primarily responsible for the oversight of the CAPA process and procedures, and ensure it is compliant, effective and efficient in dealing with quality issues. The Staff Specialist, CAPA will, through expertise in problem solving methodology, facilitate proactive and effective resolution of issues.

Working within the QMS team, under minimal supervision, ensure compliance to CAPA processes and procedures and is responsible to, but not limited to.

  • Have responsibility 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.
  • Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC / CAPA process.
  • Contribute in developing optimum future state of the NC / CAPA process for business needs, aligned with Corporate
  • Develop & deliver training and coaching for new CAPA users on CAPA principles and on the system
  • Coordinate between potential different organizations which have to interface
  • Ensuring users provide the necessary rigor to the eCAPA system content including maintaining a live document with all relevant evidence attached, in a timely manner.
  • As Problem Solving Methodology expert, 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.
  • Subject Matter Expert on all related procedures, ensuring compliance to the relevant Corporate procedures. Super user of eCAPA system.
  • Lead & execute the NC/CAPA Review board forums. Chair and lead Global/ multi-site forums.
  • Manage & monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums, also liaising with other GQO sites to ensure compliance to global requirements & metrics are achieved.
  • Ensure adequate training is developed, maintained and provided to all users of CAPA process & systems.
  • Identify and lead continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
  • Provides review and input into global procedures.
  • Identify opportunity for improvement, lead &/or participate in cross-plant and corporate project teams in areas of CAPA and quality systems improvement.
  • Lead/coordinate preparation, participate and follow up to Stryker Internal, Corporate and third party compliance audits.

What you need

  • Bachelor degree in a Science, Engineering or related discipline.
  • Masters of Science, Engineering preferred
  • Minimum of 4 years' experience in area of quality systems or engineering or equivalent experience, with minimum of 2 years' experience in area of CAPA.
  • Minimum of 6 years in Quality/Regulatory Affairs environment preferred
  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.

Keywords: Stryker Corporation, Flower Mound , Staff Specialist, CAPA, Other , Flower Mound, Texas

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