Remote QA Specialist - Medical Devices (EMEA)

Abbott; Witney; Remote; GBP 40,000 - 60,000; Full time

Job summary

Abbott in the United Kingdom is seeking a QA Specialist to support commercial Quality Assurance and Regulatory Compliance across the EMEA region, based in Solihull, with responsibilities to ensure compliance with quality management systems, ISO standards, and medical device regulations.

You will collaborate with affiliates, distributors, and cross‑functional teams to maintain warehousing, inventory, and distribution quality, manage CAPAs, audits, and deliver quality training while supporting

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Quality, or related field.
• 2–4 years of experience in Quality Assurance or related regulated industry.
• Knowledge of ISO 13485 and Medical Device Regulations.
• Experience working within a Quality Management System (QMS).
• Strong analytical, problem-solving, and investigation skills.
• Experience managing CAPAs and supporting audits.
• Excellent communication and stakeholder management skills.
• Ability to work effectively in a cross-functional and international environment.

Responsibilities

• Implement and maintain QA requirements for warehousing, inventory, and distribution across EMEA.
• Support QA processes with affiliates, distributors, and logistics partners.
• Collaborate with Sales, Marketing, Customer Service, and Supply Chain to align quality requirements.
• Support distributor onboarding and annual contractual quality processes.
• Monitor field inventory quality and help identify, escape, and mitigate quality risks.
• Manage CAPA investigations and ensure timely corrective and preventive actions.
• Deliver quality training initiatives related to inventory, warehousing, and distribution.
• Participate in audits and support audit readiness across affiliates.
• Assist with development and maintenance of quality procedures and documentation.

Skills

Quality Assurance

Regulatory Compliance

ISO 13485

QMS

Analytical skills

Stakeholder management

Education

Bachelor's Degree in Life Sciences

Bachelor's Degree in Engineering or Quality

Tools

QMS software

Job description

Abbott in the United Kingdom is seeking a QA Specialist to support commercial Quality Assurance and Regulatory Compliance across the EMEA region, based in Solihull, with responsibilities to ensure compliance with quality management systems, ISO standards, and medical device regulations.

You will collaborate with affiliates, distributors, and cross‑functional teams to maintain warehousing, inventory, and distribution quality, manage CAPAs, audits, and deliver quality training while supporting