Senior Specialist - CAPA & NC

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 the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

Why regulatory affairs/quality assurance at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities. If you are interested in working at one of the World’s Best Workplaces, apply now!

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

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

Stryker’s Salt Lake City, UT location has a fantastic Senior Specialist - CAPA & NC opportunity. We are seeking a passionate cross-functional team member who can drive action through the corrective/preventive actions (CAPA) process. The Senior CAPA Specialist 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. You will, through expertise in problem solving methodology, facilitate proactive and effective resolution of issues.

• Responsible for review and approval of NCs and CAPAs; review for completeness, accuracy, effectiveness, and timeliness. Review and approval of CAPA changes including extension requests.
• Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC / CAPA process.
• Ensure users provide the necessary rigor to the eCAPA system content, including maintaining a live document with all relevant evidence attached.
• As Problem Solving Methodology expert, facilitate and coach NC and CAPA teams in the application of problem-solving techniques, and promote its use and development, e.g. Human Error Reduction.
• Subject Matter Expert on all related procedures, ensuring compliance to the relevant corporate procedures. Super user of eCAPA system.
• Lead and execute the NC/CAPA Review Board forums. Lead multi-site forums and participate in global forums.
• Manage and monitor site NC/CAPA KPIs including reporting requirements, and providing detailed updates and information in support of quality and business review forums; also liaise with other GQO sites to ensure compliance to global requirements and metrics are achieved.
• Ensure adequate training is developed, maintained, and provided to all users of CAPA process and systems.
• Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
• Lead and/or participate in cross-plant and corporate project teams in areas of CAPA and quality systems improvement.
• Lead/coordinate preparation, participation, and follow-up to Stryker Internal, Corporate, and third-party compliance audits.

What you need

• Bachelor’s degree in science, engineering, or related subject required.
• Master’s Degree in science or engineering preferred
• Minimum of 2 years’ experience in the area of quality systems in a regulated environment required.
• Minimum of 3 years’ experience in regulated environment (medical devices, automotive or aerospace) highly preferred.
• Having a CAPA background; ownership of NC/CAPA preferred.
• Strong knowledge of supporting Quality Systems (e.g. Audits, Management Review, Quality Planning) preferred

Our benefits

Our total rewards offering varies by country but often includes bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

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 at https://careers.stryker.com/referrals/