Head of Quality/Quality Manager

STEM Recruitment Partners
Employment Type
Not disclosed
STEM Recruitment Partners logo

Head of Quality/Quality Manager
Our client, a medical device multinational site in Southeast Ireland, is a true Irish success story. They have been in business for over 20 years and have over 260 staff onsite. Due to their success, our client is looking for a Head of Quality/Quality Manager looking to progress their career to be part of the site management team role. Reporting directly to the CEO, my client is looking for an inspiring leader who will train, mentor, and develop the quality department. You will be supported by an established team with a wealth of experience to share.
Meet your potential new employer?
A highly successful medical device company based in the Southeast has a world-class manufacturing facility with state-of-the-art precision machining systems. Our client is a hugely successful contract manufacturer partnering with leading medical device companies worldwide. They are continuously innovating and have exciting new innovative life-saving products always coming online. This is a great time to join their team as they have been so successful with their customers that they have exciting plans in place for expansion. I was onsite with this company today and I was super impressed with the facility and everyone I met, especially the staff in the management team. You can see they have created a good culture and promote a good work-life balance; most staff finish by 4.30 pm and earlier on a Friday.
If you are currently a Quality Manager looking to be part of the management site team or a Senior Quality Engineer with team lead experience, who has temporarily worked as a Quality Manager from time to time, this is the role for you. We are looking for someone who really wants to put their stamp on this role, where you can make a real impact and be a part of their success story. 
The Rewards
An excellent package including (Excellent basic, Bonus, Shares, Pension, Family Healthcare, Life Cover, and Disability Cover)
The Role
Reporting to the CEO, the Quality Manager will be responsible for:

  • Lead and develop the team.
  • Proactively develop sustainable goals and targets for each team member.
  • Conduct Performance reviews, RTW, probation reviews etc.
  • Design, maintain and implement training programmes as agreed with management.
  • Plan and monitor internal audit schedule.
  • Responsible for in-house standards for quality.
  • Remain up to date with ISO requirements and ensure the company is audit ready.
  • Quality system development, implementation & maintenance
  • Supervising the programme of internal auditing and calibration.
  • Development, Maintenance, and Approval of Standards.
  • Providing support to Regulatory and Customer audits.
  • Ensuring that processes meet with ISO and AS requirements.
  • Assessing product specifications and customer requirements and ensuring they are met.
  • Monitoring performance by gathering data and producing reports.
  • Managing quality issues to ensure timely and effective corrective actions to prevent re-occurrence.
  • Supplier and Customer Liaison on Quality Issues.
  • Provide validation expertise to maintain validated status for the facility.
  • Monitoring the ongoing performance and outputs of the quality process and providing updates to managers and directors around quality issues.
  • Supplier and Customer Liaison on Quality Issues.
  • Provide validation expertise to maintain validated status for the facility.
  • Oversee the design and execution of commissioning and validation protocols on manufacturing equipment, software, and process, and approve validation documentation.
  • Maintain an understanding of cGMP regulations and guidance in relation to all aspects of qualification of process and equipment.
  • Coordinate validation activities to ensure schedule adherence and compliance.
  • Using statistical analysis, measure, control, and improve product and process robustness.

Experience Required

  • Experience in Quality management, including quality systems management.
  • 6+ quality experience in manufacturing
  • Post-graduate degree in a technical or regularity discipline desirable
  • Thorough understanding of ISO 13485
  • Experience leading and developing teams.
  • Experience with FDA regulations desirable

Next Step
Click Apply Now and Teresa Tyler will come back to you ASAP to support you in your application.