Quality Engineering Manager

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

Job summary

Life Science Recruitment represents a medical device client seeking a senior QA leader in Galway. The role manages the QMS, regulatory compliance and product release activities, partnering with cross-functional teams to sustain quality across manufacturing processes.

The candidate will drive internal audits, CAPA handling, and management reviews while liaising with customers and certification bodies to uphold ISO13485 and 21 CFR Part 820 standards.

Qualifications

• 5–10 years of progressive experience in quality assurance and control within medical device manufacturing or related industry.
• Proven leadership and ability to guide teams.
• Solid knowledge of ISO 13485, FDA 21 CFR Part 820, and/or Medical Device Directives.
• Proficiency with engineering quality tools (FMEA, DOE, SPC and related statistical methods).
• Ability to support product development, manufacturing and release activities as directed by senior management.
• Excellent technical writing and verbal communication skills.

Responsibilities

• Ensure QMS processes and documentation are established, implemented and maintained per ISO 13485, ISO 9001 and 21 CFR Part 820.
• Promote awareness of 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 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 standards and procedures.
• Handle CAPA, customer complaints and feedback for timely resolution and continuous improvement.

Skills

Leadership

Communication skills

Technical writing

Tools

FMEA

DOE

SPC

Statistical analysis

Job description

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.