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Senior CAPA Specialist

Job Title: Senior CAPA Specialist
Contract Type: Permanent
Location: Cork
REF: 93079
Job Published: about 1 month ago

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

Senior CAPA Specialist
Our client, a medical device company in Cork are currently looking to recruit a Senior CAPA Specialist for their site.

The successful candidate will be:
  • 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. 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

Minimum Qualifications
  • Bachelor degree/ Masters of Science, Engineering or equivalent/ related subject required,
  • 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.?

For further information on this Senior CAPA Specialist role in Cork please contact Bimi Felix on 086 8395533 /
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