Senior CAPA Specialist - Model Farm Rd in Cork at Stryker Corporation

Date Posted: 10/24/2020

Job Snapshot

Job Description



Are you looking for a company where you will be valued, supported and where you can grow your career? Do you have a background in Quality/Engineering?



If so, we have the role for you!




We are hiring a Senior CAPA Specialist who will work remotely to support Stryker's Neurovascular facility in Cork.





Every day in our Neurovascular manufacturing site in Cork we make products that save our patients lives! This is an opportunity for you to become a key part of that of that!



Who We Want:



  • Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.



  • Dedicated achievers. 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.



  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.









What You Will Do:





  • The Senior 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 Senior Specialist, CAPA will, through expertise in problem solving methodology, facilitate proactive and effective resolution of issues. ​



  • 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.



  • 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. Lead multi-site forums and participate in global 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 continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.



  • 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:



  • Minimum of 2 years’ experience in area of quality systems or engineering or equivalent experience.



  • Minimum of 4 years in regulated environment required.



  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.



  • Thorough knowledge and understanding of US and International Medical Device Regulations.



  • Strong knowledge of supporting Quality Systems (e.​g.​  Audits, Management review, Quality Planning).



  • Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.



  • Strong interpersonal skills.



  • Strong written and oral communication and negotiations skills.



  • Strong in critical thinking and "outside the box" thinking.



  • Highly developed problem solving skills.



  • Strong analytical skills.



  • Demonstrated ability to successfully manage and complete projects in a matrix organization.



  • Demonstrated ability to work independently.



  • Experience in working in a compliance risk situation.



  • Demonstrated knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply.



  • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages



  • Some travel may be required.​














Work From Home: Remote

Travel Percentage: None

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