Quality Specialist – CAPA/NCR | Collins McNicholas

Quality Specialist – CAPA/NCR

  • Reference: CJ43785
  • Job Type: Permanent
  • Location: Cork, Cork City
  • Category: Production

Job description:

  • Manage CAPA/NCR activities for the Cork Instruments site, acting as a liaison between Quality Assurance and Manufacturing in the area of CAPA/NCR.
  • Act as the local SME on all related procedures, ensuring compliance to the relevant divisional and corporate procedures.
  • Liaise with other Stryker plants in the division to ensure that compliance to CAPA/NCR divisional and corporate requirements is achieved.
  • Liaise with the division and other Stryker CAPA/NCR groups to support CAPA/NCR related requests and activities (review boards).
  • Participcate and contribute to Divisional activities related to the CAPA/NCR process. (NCRB, NCR summits etc).
  • Ensure adequate training is developed and provided to all users on the CAPA/NCR system and relevant problem solving tools.
  • Co-ordinate, facilitate and promote the use of suitable root cause and problem solving methodoligies within Stryker.
  • Prepare for quality reviews (QA/RA Business reviews, management review, NCRB). Liaising with the Q&R analyst, preparation of the power point pack through analysis of inputs/trends, organization/reporting of the meeting and coordinating the inputs from all disciplines of the quality or manufacturing group in preparing the review.
  • Lend support to day-to-day activities related to CAPA/NCR and problem solving.
  • Lead/coordinate preparation, participate and follow up to Stryker Internal, Corporate and third party compliance audits.
  • Participate in multi-functional teams set up to drive Quality.
  • Lead & participate in cross-plant and divisional project teams in areas of compliance and quality systems improvement.

Minimum Qualifications          

  • A Degree in Science or Engineering or equivalent discipline is required.
  • 3-5 years industrial experience in a Quality Assurance compliance position and exposure to Regulatory Agencies such as the FDA and/or Notified Bodies is desired.
  • Excellent communication, organisation and time management skills with the ability to manage several priorities at once will be required as will a high level of flexibility with a high level commitment to success.
  • High level of PC skills required.
  • The successful candidate must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages


For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email emer.ocallaghan@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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  • Emer O'Callaghan
  • Recruitment Consultant
  • 0214911061
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