The Opportunity
Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. Our in-vitro Diagnostic Assay manufacturing site in Dundee has an exciting opportunity for a Product Quality Assurance Manager to join the Dundee Operations department. This is a 1st line leadership role.
What You’ll Do
As the Product Quality Assurance Manager you will:
1. Provide strategic oversight of:Independent approval of raw materials, intermediates, and finished products via Quality Record Audits and physical inspections.Product design, process, and facility changes through the Design Quality Group.Complaint intake, reportability assessment, investigation, and resolution via the Product Support Team.Nonconformance and CAPA processes.Supplier Quality Assurance activities.
2. Act as Depute Person Responsible for Regulatory Compliance (PRRC), ensuring final release of finished IVDs.
3. Lead external audit and inspection programs.
4. Represent QA in Tier 4 & 5 Management Operating System reviews and team briefings.
5. Drive continuous improvement initiatives across cost, quality, and delivery metrics.
6. Recruit, develop, and manage a high-performing QA team.
7. Conduct monthly and annual performance reviews.
8. Foster a culture of accountability, ownership, and excellence.
9. Promote clear expectations and career development for Production Scientists.
Required Qualifications / Profile
10. Degree level or equivalent, preferably a life science subject area
11. Experience in similarly regulated industry preferred
12. Demonstrable leadership and management capabilities
13. A practical understanding of record audit and material approval processes per ISO 13485:2016 for the Design and Manufacture of In-vitro Diagnostics
14. A comprehensive technical understanding of the function and performance characteristics of the products and materials produced within the Operations environment.
15. An ability to employ state-of-the-art Root Cause Analysis (RCA) tools, including A3/DMAIC.
16. The capability to contribute to and perform Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA).
17. Experience with an Enterprise Resource Planning System (ERP)
18. Experience with Electronic Document Management Systems (EDMS)
19. Proficient with MS Word, Excel and Power-Point.
As you’d expect from an innovative global health care company, we offer a competitive range of benefits including excellent salaries, a class-leading defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme.
Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. Joining us, you can shape your career as you shape the future of healthcare.
With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.