Job Description

Location: Galway, Ireland Department: Quality Assurance & Quality Engineering

Make a Global Impact in Medical Device Quality

Are you an experienced quality leader looking to take your career to the next level in a dynamic and high-impact environment? We are seeking a Senior Quality Manager to lead and shape the Quality Assurance and Quality Engineering functions at our Galway site. This is a key leadership role within a global organisation committed to excellence in medical device manufacturing and compliance.

Reporting directly to the Global Head of Quality Operations, you will play a critical role in driving quality strategy, maintaining compliance across international regulatory standards, and leading a team of dedicated quality professionals.

What You'll Be Responsible For:

• Leading and developing the Quality Assurance, Quality Engineering, Validation, Calibration, and Microbiology teams on-site.

• Ensuring compliance with global regulatory requirements including 21 CFR 820, ISO 13485, MDR, RDC ANVISA 16/2013, MHLW MO 169, and TG(MD)R Schedule 3.

• Overseeing Material Review Boards (MRBs) to ensure timely and compliant product disposition and initiation of corrective/preventive actions.

• Developing robust systems to support design and production teams in areas such as:

o Quality planning and inspection methods

o Statistical analysis and sampling

o Sterilisation and biological testing

o Application of regulatory standards

• Managing quality controls across the full product lifecycle — from raw material intake to final product release.

• Leading regulatory and customer audits and ensuring audit readiness at all times.

• Driving improvements through structured problem-solving, failure analysis, and CAPA programs.

• Partnering with suppliers to maintain and elevate incoming material and component quality.

• Mentoring and training team members in quality engineering principles, including probability and statistics.

• Tracking departmental metrics, setting clear objectives, and supporting continuous improvement.

What We are Looking For:

• A degree in Engineering or a scientific discipline.

• At least 10 years of experience in a regulated medical device environment, with senior leadership exposure.

• ASQ Certified Quality Engineer (CQE) and/or Six Sigma Green/Black Belt certification preferred.

• Strong working knowledge of international medical device regulations.

• Proven leadership and team development capabilities.

• Excellent analytical, communication, and project management skills.

• High proficiency in quality tools, statistical methods, and problem-solving techniques.

Key Competencies:

• Leadership & Team Management

• Regulatory Knowledge & Compliance

• Risk-Based Thinking

• Data Analysis & Statistical Applications

• Strategic Planning & Execution

• Continuous Improvement Mindset

Why Join Us?

This is a rare opportunity to take ownership of a site-wide quality function at a senior level. You will be empowered to lead change, shape quality culture, and work in a collaborative environment where innovation, compliance, and patient safety are top priorities.

For further information on this Senior Quality Manager role in Galway please contact Caroline Kingston on +353 868395531 or email caroline@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/.

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA based on standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.