Quality Specialist

EFOR; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

EFOR is seeking a Medical Device Combination Product Quality Specialist to join our Global Quality Organisation. You will ensure the highest quality standards for combination products by acting as a liaison across quality and operations teams.

You will support QMS processes, change controls, CAPAs, and deviations, while engaging with cross-functional, global stakeholders to drive compliance and continuous improvement.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Quality, or related field.
• Experience in a regulated medical device, pharmaceutical, or combination product environment.
• Solid understanding of QMS, such as ISO 13485, 21 CFR Part 820, or similar.
• Hands-on experience with change control, CAPA, and quality records management.
• Strong communication and cross-functional collaboration.

Responsibilities

• Provide quality support and oversight for combination product lifecycle management.
• Maintain QMS records related to combination products (change controls, CAPAs, deviations).
• Serve as a quality liaison between Medical Device Quality, Operations Quality, Central Quality, Supplier Quality, CMOs, and QC.
• Facilitate communication across global and cross-functional teams to enable effective decision-making on quality and compliance matters.
• Participate in and support audits, regulatory inspections, and continuous improvement initiatives.
• Track, analyze, and report on quality metrics and trends for combination products.
• Ensure documentation and processes meet all internal standards and external regulatory requirements.

Skills

Quality management systems

CAPA

Change control

Regulatory inspections

Cross-functional collaboration

Quality liaison

Education

Bachelor's degree in Life Sciences/Engineering/Quality

Job description

Medical Device Combination Product Quality Specialist

Join a collaborative and ambitious team where diverse perspectives fuel life-changing innovations. As a Medical Device Combination Product Quality Specialist in our Global Quality Organisation, you will ensure the highest quality standards for combination products by acting as a crucial quality liaison and supporting key quality management processes.

Key Responsibilities:

• Provide quality support and oversight for combination product lifecycle management activities
• Manage and maintain compliance with Quality Management System (QMS) records related to combination products (including change controls, CAPAs, and deviations)
• Serve as a quality liaison between Medical Device Quality, Operations Quality, Central Quality, Supplier Quality, CMOs, and Quality Control (QC)
• Facilitate efficient communication across global and cross-functional teams to enable effective decision-making on quality and compliance matters
• Participate in and support audits, regulatory inspections, and continuous improvement initiatives
• Track, analyze, and report on quality metrics and trends for combination products
• Ensure documentation and processes meet all internal standards and external regulatory requirements

Requirements:

• Bachelor’s degree in Life Sciences, Engineering, Quality, or related technical field (advanced degree a plus)
• Experience in a regulated medical device, pharmaceutical, or combination product environment
• Solid understanding of Quality Management Systems (QMS), such as ISO 13485, 21 CFR Part 820, or similar
• Hands-on experience with change control, CAPA, and quality records management
• Strong communication skills and ability to work collaboratively in a cross-functional, global environment
• Experience supporting regulatory inspections and audits (preferred)
• Strong analytical, problem-solving, and organizational skills
• Ability to adapt to shifting priorities while maintaining a commitment to compliance and quality