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Collins McNicholas

One of our key clients based in Co. Mayo is seeking a Site Quality Manager to join their business on a permanent basis. The company in question is a contract sterilization and microbial reduction service who have been in operation for over 40 years providing services to the Medical Device, Pharma, Consumer and R&D industries. Their main goal is to help customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Key Duties

  1. The Site Quality Manager has specific and general responsibilities in respect to the Quality System and will be the designated management representative for the site (audits, report generating, quality plans, ongoing compliance)
  2. Responsible for ensuring appropriate systems for the release of client product post-processing.
  3. Analyses Customer complaints and implements corrective actions for valid complaints.
  4. Responsible for Document Control function.
  5. Responsible for facilitating Customer and Regulatory audits including generation of corrective actions
  6. Responsible for ensuring process commissioning, validation and any subsequent re-validation deemed
    necessary as a result facility engineering changes or customer product/requirements changes
  7. Provides technical assistance and support to Customers in the development of validation protocols subsequent validation reports, and routine processing problems.
  8. Responsible for ensuring process, test and raw materials specifications remain current, by conducting internal audits, ensures that these specifications are met.
  9. To ensure compliance with safety procedures at all times.
  10. Provides support to ongoing continuous improvement efforts and LEAN activities

Required Experience

  • Vocational/Technical in Science or Bachelor’s Degree in Science
  • 3-5 years relevant industrial experience with Quality Systems/Engineer in ideally medical device or pharma
  • Requires comprehensive knowledge and hands-on experience of quality standards and procedures;
  • ideally in the area of sterilisation and validation.
  • Working knowledge and experience of medical device manufacturing, related GMP and an appreciation of FDA compliance inspections.

Salary/Benefits

  • Salary is competitive although DOE
  • Pension contribution
  • Healthcare
  • Performance related bonus
  • 20 days annual leave

Please get in touch for more info on elaine.dolan@collinsmcnicholas.ie or 091 706 718

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