Quality Engineering Manager

Life Science Recruitment; Galway; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Top salary

Bonus

Pension

Healthcare

Job summary

Life Science Recruitment is seeking a Quality Manager for a Galway-based medical device manufacturer. You will lead the QA program, ensuring ISO 13485, FDA 21 CFR Part 820 compliance, and management of CAPA, audits, and continuous improvement.

Responsibilities include maintaining QMS documentation, internal audits, and acting as the main liaison with customers and certification bodies. Strong leadership and regulatory knowledge are essential.

Qualifications

• 5–10 years of progressive experience in quality assurance and control within medical device manufacturing or related industry.
• Strong leadership and people-management skills.
• Solid knowledge of ISO 13485, FDA 21 CFR Part 820, and/or Medical Device Directives.
• Proficiency with quality engineering tools (FMEA, DOE, SPC) and statistical analysis.

Responsibilities

• Establish, implement, and maintain QMS processes in line with ISO 13485, ISO 9001 and 21 CFR Part 820.
• Promote regulatory and customer requirements across the organization and ensure compliance.
• Serve as primary liaison with customers and certification bodies for external audits.
• Provide leadership on QA matters, including quality systems and material disposition.
• Ensure management reviews are conducted per regulatory requirements.
• Oversee document/record control for products, processes and QMS.
• Plan and conduct internal quality audits for compliance.
• Handle CAPA, customer complaints and feedback for timely resolution and improvement.

Skills

Leadership

Regulatory knowledge

Quality tools

Technical writing

Tools

FMEA

DOE

SPC

Job description

Job title: Quality Manager

Location: Galway

Benefits:

Top salary, Bonus, pension, healthcare

Company:

My client are a Medical device manufacturer with a new hub in Galway. They specialise in catheters, medical balloons, EM-Micro Sensors, engineered shafts, and complete device assemblies, supporting a wide range of interventional therapies.

Responsibilities:

• Ensure the QMS processes and documentation are established, implemented, and maintained in compliance with ISO 13485, ISO 9001, and 21 CFR Part 820.
• Promote awareness of regulatory and customer requirements across the organization and ensure compliance.
• Serve as the primary liaison with customers and certification bodies for external audits.
• Provide leadership and direction on all QA-related matters, including quality systems, compliance, and material disposition.
• Ensure management review meetings are conducted in accordance with regulatory requirements.
• Oversee control of documents and records related to products, manufacturing processes, and the QMS.
• Plan, manage, and conduct internal quality audits to ensure compliance with applicable standards and internal procedures.
• Handle and monitor CAPA, customer complaints, and feedback to ensure timely resolution and continuous improvement.

Requirements: Education/Experience and Qualifications:

• 5–10 years of progressive experience in quality assurance and control within medical device manufacturing or a related industry, with in-depth knowledge of manufacturing processes and quality systems.
• Strong management and leadership skills.
• Solid knowledge of ISO 13485, FDA 21 CFR Part 820, and/or Medical Device Directives.
• Demonstrated proficiency in engineering and quality tools (e.g., FMEA, DOE, SPC, and statistical analysis tools).
• Ability to support product development, manufacturing, and product release activities as directed by senior management.
• Excellent technical writing and verbal communication skills.