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Collins McNicholas

Title:  Site Quality Manager

Description:

At company X, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary:

Plans and maintains Quality Assurance Systems to ensure process and test reliability and conformance to Customer and Regulatory requirements. Responsible for the management of the release process for sterilization master batch records.

As a member of the Site Management team contributes to the performance of the Company and provides inputs and suggestions on normal routine business matters.  In conjunction with the Ireland (Country) QA Manager, responsible for Quality Assurance and Technical matters relating to the EO, Laboratory, E-Beam facility.

Reports:

Quality Release Supervisor

Quality Engineers

Quality Technician 

Quality Release Technicians

Quality Administrator

Duties

  • The Site Quality Manager is the management representative identified in the Quality Manual with the authority and responsibility to ensure the documented Quality System is implemented.
  • The site Quality Manager has specific and general responsibilities in respect to the Quality System.
  • Is the designated management representative for the Ireland Quality Manager, Manager for EO and E-beam as per Quality manual.
  • Management representative for Laboratory (Quality assurance and supporting Technical matters). Site Quality Manager will have an indirect reporting line to the Laboratory Quality Director.
  • Ensure Audits, associated reports, and quality plans are implemented and verifies that the necessary corrective actions are taken to ensure ongoing compliance with the Quality Manual.
  • Responsible for ensuring appropriate systems for the release of client product post-processing.
  • Analyses Customer complaints and implements corrective actions for valid complaints.
  • Responsible for facilitating Customer and Regulatory audits including generation of corrective actions and ensuring responses to the relevant third party. Ensuring the promotion of awareness of regulatory and Customer requirements throughout the organization.
  • Responsible for ensuring process commissioning, validation and any subsequent revalidation deemed necessary as a result of facility engineering changes or Customer product/requirements changes are documented, approved and implemented. 
  • Provide technical assistance and support to Customers in the development of validation protocols, subsequent validation reports, and routine processing problems.
  • Responsible for ensuring process, test and raw materials specifications remain current, by conducting internal audits ensures that these specifications are met. 

Education

Bachelor’s Degree in Engineering General

Associate’s Degree in Science

Required Experience

  • Life Science/Engineering Qualification and 3-5 years of relevant industrial experience with Quality Systems.
  • Requires comprehensive knowledge and hands-on experience of quality standards and procedures; ideally in sterilization and validation (but not essential).
  • Working knowledge and experience of medical device manufacturing, related GMP and an appreciation of FDA compliance inspections
  • Ability to work well with people and act as a facilitator to staff not directly reporting to this position is important.
  • Ability to communicate with clients is essential.

 

For a confidential discussion and more information on the role, please contact David Lennon on 090 64 78104 or email david.lennon@collinsmcnicholas.ie

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