Head of Quality

Location: Cork City, Cork Salary:
Sector: Quality Assurance (QA) Type: Permanent

Why should I apply for Head of Quality?

My client are a leading medical device company based in Cork. An exceptional opportunity has come up within the company as Head of Quality. The role come with an excellent benefits package and competitive salary.

Reporting directly to the Vice President, Global Quality Operations and indirectly to the General Manager, you will be responsible for managing and directing the Quality Assurance Departments of: Quality Systems, Documentation Control, Quality Control, Quality Engineering, Regulatory Affairs, Complaint Handling and Laboratory Services to ensure that products manufactured and established systems comply with GMP, ISO and applicable regulatory and company requirements. You will also provide direction on the use of quality systems and tools with a focus on process improvements and is responsible for acting as the Facility Management Representative.

What will I be doing as Head of Quality?

  1. Perform the duties as Facility Management Representative in accordance with FDA and ISO requirements to ensure overall Quality System is implemented and effective.
  2. Ensure that processes needed for the quality system are established, implemented and maintained. Maintain the facility compliance to FDA QSRs, ISO 13485, applicable MDD and Canadian requirements together with other applicable International Standards and regulatory requirements.
  3. Report to management on the performance of the quality system and any need for improvement.
  4. Ensuring the promotion of awareness of regulatory and customer requirements throughout the organisation. Promote process improvements through the use of recognised quality tools, internal audit program, appropriate CAPA systems and feedback systems (complaints etc.).
  5. Implement systems and controls to prevent product recalls and manage and post-market surveillance actions in accordance with regulations and corporate requirements. Maintain responsibility for the systems that control/ensure the sterility of product and the release of product to the marketplace.
  6. Responsible for registration of products in all identified market places to support start build plan requirements and for maintaining registrations current. Maintain a change control system with appropriate controls which comply with applicable regulations.
  7. Manage and maintain a suitability resourced QA Dept. with appropriately qualified personnel (i.e. Labs, Documentation, RA, Quality Engineering, Quality Compliance, Complaints, QC, Calibration and Supplier mgt.) to support facility needs and comply with international regulations. Manage personnel over three shifts. Maintain high morale within and across departments; handle personnel problems fairly and honestly in a timely manner. Promote cooperation and teamwork with all departments by open, candid communication and timely coordination.
  8. Ensure continual Quality System compliance by adherence to established and evolving company QS requirements.

What do I need to apply for Head of Quality?

  • Experience in the responsibilities outlined above
  • Knowledge of appropriate regulations and standards
  • Ability to manage large group of people with varied qualifications and very diverse responsibilities
  • Communications skills and ability to work with a variety of Departments, facilities and Regulatory bodies both national and international
  • Bachelor's Degree in Engineering or relevant Science discipline (level 8) - preferably Master's Degree in Engineering or related Science discipline.
  • You are also required to have 5-10 years' experience in a Medical Devices / pharmaceutical industry, including with 5 years of supervisory experience.
  • EU passport / Stamp 4 Visa for consideration.

Interested? Apply with your recent CV if you meet these requirements. If your CV has not been updated but you would like to hear more, please apply with a brief cover letter and I can follow up with you.

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