- Reference: 42933
- Job Type: Permanent
- Location: Dublin City Centre, Mainland Europe, Westmeath
- Category: Bio-Pharmaceutical
Role: European Manager of Quality- (Sterlization & Microbiology).
We are recruiting for a leading Medical Devices organisation a Director level role – with responsibility for implementing and directing the QA policies across the organisation’s multi-sites in Europe and ASIA, with particular responsibility for the sterilization, microbiology and environmental control functions. This role given the scope and regional responsibility will require travel across the European sites. The role can be based from Dublin or one of the other Irish sites – Midlands or Galway. This is a great opportunity to be part of a corporate global team and will offer a challenge and rewarding career path for the right individual.
Directs implementation of sterilization validation, microbiology, environmental control, and bio-compatibility reviews at the direction of the Sr. Director of Sterilization through Global Policies. Responsible for continuously reviewing Medical Devices regulation, FDA regulations, ISO standards, quality assurance philosophy, practice, and procedure to recommend compliant procedures and cost effective solutions.
Establishes and ensures maintenance of training programs for quality control personnel in regards to sterilization and environmental control. Lead auditor for sterilization and microbiology assessments for contractors and suppliers. Key participant in product and package change control process, to identify or waive validation needs. May also direct bio-compatibility testing, FMEA, Risk Analysis, HHE.
Interface with corporate and manufacturing site representatives in regards to all subjects in sterilization and environmental monitoring controls. Extensive travel domestically and internationally.
- Identify and elevate opportunities for preventive and corrective action, assist in implementing proactive programs corporate-wide in sterilization/preservation/microbial control.
- Monitor change control of products, product transfers, processes, and facilities with regard to impact on sterilization and microbial control, by means of document change requests, audits, project participation.
- Maintain total and complete understanding and compliance with the requirements of FDA, OSHA, EPA, MDD, and organisation mandates regarding sterilization, microbiological quality control, and medical products manufacturing environments.
- Assure state-of-the-art methodology and results using documented procedures, equipment and accept/reject criteria of sterilization and environmental process and documentation.
- Establish and maintain a routine self-audit program as well as evaluation/audit of any contract sterilizers and laboratories, in concert with other business units.
- Conduct or participate as needed in internal audits and vendor audits.
- Create and devise methods to evaluate and ensure the safety of products
- Interface between the laboratory and other areas of the company to ensure test reports are clearly written and understandable and reach a final conclusion.
– Minimum degree qualified in Quality / Sterilisation / Microbiology – ideally 8 years plus at senior level
– FDA/ ISO/ GMP knowledge base / Knowledge of Regulatory Affairs
– Knowledge and involvement in International Standards Development Process
– Sterilization experience: radiation, EO, Steam, other
– Ability to plan, organize and prioritize- Ability to matrix manage projects with multiple functional groups without direct reporting authority
– Statistical Analysis capability
– Project management skills
For a confidential discussion and or more information on the role and organisation , please contact Mary Mullin on 09064 78104 /085 8718281 or email email@example.com
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