Quality Assurance Specialist.

Job description

JOB DESCRIPTION

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.

You will have access to:

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. In Abbott's Medical Devices Divisions

We are dedicated to advancing healthcare through innovative medical technologies that improve patient outcomes and transform lives. Our Medical Devices portfolio supports healthcare professionals worldwide with cutting-edge solutions across Cardiac Rhythm Management, Electrophysiology, Heart Failure, Neuromodulation, and Structural Heart therapies. The Opportunity QA Specialist This role will support the commercial Quality Assurance and Regulatory Compliance (QARC) activities across the EMEA region, based in Solihul, ensuring compliance with quality management systems, ISO standards, and medical device regulations.

The successful candidate will work closely with affiliates, third-party logistics providers, distributors, and cross-functional teams to maintain high-quality warehousing, inventory, and distribution processes. What You'll Work On Implement and maintain Quality Assurance requirements for warehousing, inventory, and distribution activities across EMEA. Support the implementation of distribution and warehousing quality processes with affiliates, distributors, and logistics partners.

Partner with Sales, Marketing, Customer Service, and Supply Chain teams to ensure alignment with quality requirements. Support distributor onboarding activities and annual contractual quality processes. Monitor field inventory quality processes and help identify, escalate, and mitigate quality risks. Support qualification, evaluation, and ongoing monitoring of third-party suppliers and distributors. Manage CAPA investigations, action plans, and timely implementation of corrective and preventive actions.

Deliver and support quality training initiatives related to inventory, warehousing, and distribution. Participate in internal and external audits and support audit readiness across affiliates. Assist with the development, implementation, and maintenance of quality procedures and documentation. Escalate warehousing, inventory, and distribution-related quality risks to the EMEA QA leadership team.

Qualifications

Bachelor's Degree in Life Sciences, Engineering, Quality, Supply Chain, or a related discipline, or equivalent professional experience. 2-4 years of experience in Quality Assurance, Supply Chain Quality, Warehousing, Distribution Quality, Medical Devices, Pharmaceuticals, or another regulated industry. Knowledge of ISO 13485 and Medical Device Regulations. Experience working within a Quality Management System (QMS) environment.

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. Join Abbott and help ensure the highest standards of quality and compliance while supporting life-changing medical technologies that improve the lives of patients across the EMEA region.

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Operations Quality DIVISION: EP Electrophysiology LOCATION: United Kingdom : Blythe Valley Park , Elder (Plot C1b), Central Boulevard Solihull ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Not Applicable