CAPA Specialist, 2 years Contract
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 RA/QA 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/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
The Specialist, CAPA will be primarily responsible for the oversight of the NC/ CAPA process and procedures, and ensure it is compliant, effective and efficient in dealing with quality issues. The Specialist, CAPA will, through building expertise in problem solving methodology, facilitate proactive and effective resolution of issues.
Working within the QMS team, under general 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.
- Liaise with relevant functional groups, facilitate and guide teams through all stages of the NC / CAPA process.
- 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.
- Exhibit ability to build expertise in facilitating NC & CAPA teams in the application of problem solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc.
- Highly proficient on NC/ CAPA procedures, and super user of eCAPA system.
- Execute the NC/CAPA Review board forums.
- Monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums, ensure compliance to global requirements & metrics are achieved.
- Identify continuous improvement and collaboration opportunities.
- Participate in cross-plant and corporate project teams in areas of NC & CAPA.
- Coordinate in preparation, participate and follow up to Stryker Internal, Corporate and third party compliance audits.
- Engineering Degree
- 2 years working experience in a regulated environment
- Quality Management System, good to have
- Must be fluent in Polish and English
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.
The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.
More information is available at stryker.com