Our client, a medical device company in Cork are currently looking to recruit a CAPA Quality Engineer for their site.
- 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 plants in the division to ensure that compliance to CAPA/NCR divisional and corporate requirements is achieved.
- Liaise with the division and other CAPA/NCR groups to support CAPA/NCR related requests and activities (review boards).
- Participate 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
- 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 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 further information on this CAPA Quality Engineer role in Cork please contact Cliona O'Malley on 091730022 / firstname.lastname@example.org
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