Manager Quality Sterilization and Micro EMEA | Collins McNicholas

Manager Quality Sterilization and Micro EMEA

  • 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.

Key Deliverable:

  • 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

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website

Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos!

Firstname (required)

Surname (required)

Your Email (required)

Your phone

Upload CV (required)

Security Code captcha


Contact Consultant

  • Mary Mullin
  • Regional Manager
  • 09064 50661
  • Connect with Mary

Budget Basics 2017

Scales with money
Tuesday afternoon, Ministers Noonan and Donohue presented the budget for 2017 to the Dail. It included a number of expected measures, along with some interesting talking points. It’s very easy to get lost in the stats, but what implications does this really have? At a breakfast briefing this morning, hosted by RBK, Ulster bank and […]
read whole article

The Olympic Recruitment Race

business man running on s track, blog 800 x 450
    The repetitiveness of applying for jobs continuously can sometimes feel like running a marathon; drawn-out, tiring, painstaking and seemingly never-ending. However, using the right tools and going about it the right away can turn a marathon into a 100 metre sprint. Preparation Have an up to date CV and cover letter ready to […]
read whole article

Job Seekers Guide

Everything you need to know to find a job, including; how to prepare a CV and cover letter, how to prepare for a job interview, how to navigate the modern job market, and much more.
view more