Job Title: Quality Manager – Medical Devices

Location: County Clare, Ireland

About the Company:

Our client, a growing contract design and manufacturing organisation in the medical device industry, is seeking an experienced and driven Quality Manager to join their team. Specialising in the development and production of cutting-edge medical devices, the company is focused on delivering exceptional quality, innovation, and compliance with global regulatory standards.

The successful candidate will need a minimum of three years people leadership experience, Senior Quality Engineers looking to take a step up into a recognised Management position will be considered as long as they have led Engineers/Technicians.

This position is based full time onsite in Shannon, Co. Clare. Flexibility may be offered in the future but initially the Quality Manager is required onsite full time.

Role Overview:

The Quality Manager will lead a small but experienced team, taking full ownership of the ISO 13485 and 21CFR 820 compliant Quality Management System, ensuring adherence to international regulations and maintaining essential certifications. The successful candidate will oversee quality oversight for both design and manufacturing projects, manage regulatory audits, and ensure continuous improvement across the business. The role will involve strong collaboration with customers, internal teams, and regulatory bodies, driving successful project completion and fostering a culture of quality and excellence.

Key Responsibilities:

Leadership & Strategy

 

• Lead the implementation of the company’s quality policies, fostering a culture of "right first time" across engineering and manufacturing operations.

 

 

• Provide leadership in customer-facing quality discussions, driving the implementation of quality plans for new clients and projects.

 

 

• Guide internal teams on industry best practices and drive continuous improvement in product performance.

 

 

• Collaborate with executives and senior managers to define strategic objectives and quality initiatives that align with company goals.

 

 

• Develop and expand the quality function, ensuring it meets the needs of a growing organisation.

 

Quality Management

 

• Oversee day-to-day management of the quality function, including audits, inspections, and quality system maintenance.

 

 

• Lead the classification and investigation of non-conformances, ensuring root causes are identified and addressed promptly.

 

 

• Manage Corrective and Preventative Actions (CAPAs) and customer complaints, implementing effective corrective actions.

 

 

• Interface with regulatory agencies and notified bodies on quality and compliance matters, ensuring all products and processes meet global standards.

 

 

• Establish and maintain robust Quality and Risk Management procedures to safeguard product safety and reliability throughout the lifecycle.

 

Team & Project Leadership

 

• Manage, develop, and mentor the quality team, ensuring they have the training and resources required to excel in their roles.

 

 

• Provide quality leadership for product development and manufacturing teams, incorporating risk assessments, statistical methods, and process control during design and manufacturing stages.

 

 

• Oversee the successful completion of quality-related activities in design and manufacturing projects, meeting project deadlines and company objectives.

 

 

• Ensure continuous improvement is embedded into new product development by applying lessons learned from existing products.

 

Supervisory Responsibilities:

 

• Manage the workload and deliverables of all quality personnel and consultants.

 

Experience:

 

• Minimum of 10 years’ experience in the medical device industry

 

 

• Proven experience working with ISO 13485, 21CFR210, and other relevant regulations.

 

 

• Knowledge of cleanroom and non-cleanroom manufacturing environments is a plus.

 

Skills:

 

• Excellent communication and leadership skills, with the ability to influence and build strong relationships across all levels of the organisation.

 

 

• Strong analytical and decision-making abilities, with a proactive, flexible approach to problem-solving.

 

 

• Expertise in driving a culture of quality systems compliance and accountability, with strong negotiation skills.

 

 

• Ability to collaborate effectively with cross-functional teams, customers, and suppliers.

 

Why This Role?

This is an outstanding opportunity for a motivated Quality Manager to take on a leadership role within a forward-thinking organisation. The role offers scope for career progression, the chance to work on cutting-edge medical devices, and the ability to shape the quality culture within a growing company.

How to Apply:

If you are passionate about quality, thrive in a dynamic environment, and are ready to take on a leadership role in the medical device industry, we want to hear from you. Apply today to be part of a growing team committed to excellence.

Please note, candidates must be eligible to work in Ireland without restriction.

For further information on this role please contact Lisa Lawlor on 0868395533 or email stem@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/  

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