Quality Assurance Manager

Achieve Search Ltd; Tullamore; On-site; EUR 72,000 - 98,000; Full time

Job summary

Achieve Search Ltd. is recruiting a Quality Manager for Tullamore to lead the Quality function in a growing Medical Device environment. This hands-on role will manage a Quality team and drive improvements across QMS, audits and compliance.

The position requires experience in regulated manufacturing, ISO 13485 knowledge, and a proactive approach to quality improvements in collaboration with Operations.

Qualifications

• Experience leading a Quality team in a regulated manufacturing setting.
• Strong knowledge of ISO 13485 and GMP.
• Proven track record in audits, CAPA and investigations.
• Hands-on leader able to partner with manufacturing.

Responsibilities

• Lead and develop the Quality team across QA & QC.
• Manage and improve the QMS to meet ISO 13485 & GMP.
• Lead internal and external audits, including customer/notified bodies.
• Oversee CAPAs, non-conformances, complaints and investigations.
• Support process and equipment validation and risk management.
• Collaborate with Operations to resolve Quality issues.
• Identify improvement opportunities across Quality systems.

Skills

Quality Management

ISO 13485

CAPA

Auditing

Education

Science/Engineering degree

Job description

Quality Manager - Tullamore Salary: Up to €85,000 + Package

Medical Device Manufacturing | Permanent | Full-time

I'm recruiting for a growing Medical Device manufacturer in Tullamore, this business is now actively looking to hire an experienced Quality Manager to lead the Quality function across the site.

The business has invested considerably over the last 12 months, with changes to the leadership team, an expanding Medical Device portfolio and further growth planned.

This is a hands on management role, leading an existing Quality team with responsibility across manufacturing Quality, Quality Systems, audits and continuous improvement. There are improvements to be made across the function, and the successful candidate will have the support of senior management to implement changes, develop the team and improve existing processes.

The Role:

Responsibilities will include:

• Lead and develop the Quality team, including Quality Engineers, Technicians and QC Laboratory personnel.
• Manage and improve the QMS, ensuring compliance with ISO 13485, GMP and relevant regulatory standards.
• Lead internal and external audits, including customer and notified body audits.
• Manage CAPAs, non-conformances, complaints, investigations and corrective actions.
• Support process and equipment validation, risk management and manufacturing improvements.
• Work closely with Operations to resolve Quality issues, assess risk and find practical solutions whilst maintaining compliance.
• Identify areas for improvement across existing Quality systems and processes.

What We're Looking For

• Quality Management experience within Medical Devices, Pharmaceuticals or another regulated manufacturing environment.
• Good working knowledge of ISO 13485 and/or other relevant Quality Management standards.
• Strong experience across Quality Systems, CAPA, investigations and auditing.
• Confidence leading audits and dealing directly with external auditors.
• Experience managing and developing a Quality team.
• A hands-on approach to Quality and the ability to work closely with manufacturing teams.
• A relevant Science, Quality or Engineering qualification.

Why Consider the Move?

This is an opportunity to take responsibility for a broad Quality function within a growing manufacturing business.

You'll be directly involved in improving existing systems, developing the team and working closely with Operations and senior management. The variety of the role also offers exposure across manufacturing Quality, Quality Systems, validation, audits and continuous improvement, rather than being limited to one particular area.

Location: Tullamore, Co. Offaly

Salary: Up to €85,000 + Package (depending on experience)

Contract: Permanent, full-time

Working arrangement: On-site