Sr CAPA Specialist (R447464)
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
As a Senior CAPA Specialist you will primarily be responsible for the oversight of the NC/CAPA process and procedures, and ensure it is compliant, effective, and efficient in dealing with quality issues.
- Ensure compliance to CAPA processes and procedures.
- Responsible for review and approval of NC and CAPAs, with attention to detail, review for completeness of actions and records, accuracy, effectivity, and timeliness along with the review and approval of CAPA changes and extension requests.
- Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC/CAPA process.
- Ensure users provide necessary rigor to the eCAPA system content including maintenance of a live record with all relevant evidence attached in a timely manner.
- Facilitate and coach NC and CAPA teams in the application of problem-solving techniques and promote its uses and development (e.g. human error reduction, 4-D, 5 Why's, fishbone diagrams, process mapping, etc.)
- Provide leadership to drive desired behaviors through the use of accountability meetings and facilitate root cause analysis workshops with CAPA owners.
- Act as a subject matter expert on all related procedures, ensuring compliance to the relevant procedures and serve as eCAPA super-user.
- Lead and execute the NC/CAPA review board forums; may lead multi-site forums and participate in global forums.
- Manage and monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality and business review forums, liaise with other 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 the improvement and optimization of business processes and results.
What you need
- Bachelors in a science, engineering, or related discipline.
- 2 years’ experience in manufacturing or regulated industry, ideally with quality systems
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) highly preferred
- Demonstrated knowledge of U.S., European, and international medical device regulations guidelines/standards and ability to interpret and apply highly preferred
- Strong knowledge of supporting Quality Systems (audits, management review, quality planning, etc.) highly preferred
- Some travel may be 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.