- Reference: CJ43785
- Job Type: Permanent
- Location: Cork, Cork City
- Category: Production
- 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.
- 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 email@example.com
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