Product Quality Assurance Manager

Abbott; Dundee; On-site; GBP 45,000 - 65,000; Full time

Job summary

A healthcare company in Dundee is seeking a Product Quality Assurance Manager to oversee quality processes for in vitro diagnostics. This role requires leadership in managing QA teams, driving continuous improvement, and ensuring compliance with regulatory standards. Candidates should have a degree in a life-science field, demonstrate management capabilities, and possess knowledge of quality assurance practices. Competitive benefits are offered, including healthcare and a flexible benefits scheme.

Benefits

Competitive salary

Defined contribution pension scheme

Private healthcare

Life assurance

Flexible benefits scheme

Qualifications

• Degree level or equivalent, preferably a life-science subject area.
• Experience in a similarly regulated industry preferred.
• Demonstrable leadership and management capabilities.
• Understanding of record audit and material approval processes.
• Technical understanding of product and material performance.

Responsibilities

• Provide oversight of raw materials and finished products approvals.
• Management of complaint investigations and resolutions.
• Lead external audit and inspection programs.
• Recruit and develop a high-performing QA team.
• Drive continuous improvement initiatives.

Skills

Quality Assurance

FDA Regulations

Food Industry

ISO 9001

Selenium

HACCP

Education

Degree in life-science subject area

Tools

Enterprise Resource Planning System (ERP)

Electronic Document Management Systems (EDMS)

MS Word

Excel

Power-Point

Job description

JOB DESCRIPTION : Abbott

At Abbott diverse ideas perspectives and expertise allow us to create the life‑changing solutions that help people live healthier 196 countries and with businesses spanning nutrition diagnostics medical devices and branded generic pharmaceuticals Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

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 Youll Do

• 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.
• Act as Deputy Person Responsible for Regulatory Compliance (PRRC) ensuring final release of finished IVDs.
• Lead external audit and inspection programs.
• Represent QA in Tier 4 & 5 Management Operating System reviews and team briefings.
• Drive continuous improvement initiatives across cost, quality and delivery metrics.
• Recruit, develop and manage a high‑performing QA team.
• Conduct monthly and annual performance reviews.
• Foster a culture of accountability, ownership and excellence.
• Promote clear expectations and career development for Production Scientists.

Required Qualifications / Profile

• Degree level or equivalent, preferably a life‑science subject area.
• Experience in a similarly regulated industry preferred.
• Demonstrable leadership and management capabilities.
• A practical understanding of record audit and material approval processes per ISO 13485:2016 for the Design and Manufacture of In‑vitro Diagnostics.
• A comprehensive technical understanding of the function and performance characteristics of the products and materials produced within the Operations environment.
• An ability to employ state‑of‑the‑art Root Cause Analysis (RCA) tools including A3 / DMAIC.
• The capability to contribute to and perform Risk Assessments, Risk Management/Control exercises and Failure Mode Effect Analyses (FMEA).
• Experience with an Enterprise Resource Planning System (ERP).
• Experience with Electronic Document Management Systems (EDMS).
• Proficient with MS Word, Excel and Power‑Point.

Key Skills

• Quality Assurance
• FDA Regulations
• Food Industry
• Food Safety Experience
• ISO 9001
• Quality Systems
• Food Processing
• Quality Control
• Quality Management
• QA / QC
• Selenium
• HACCP

Other Details

JOB FAMILY : Operations Quality

DIVISION : CMI ARDx Cardiometabolic and Informatics

LOCATION : United Kingdom

Dundee : 17 Luna Place

WORK SHIFT : Standard

TRAVEL : No

MEDICAL SURVEILLANCE : No

SIGNIFICANT WORK ACTIVITIES : Not Applicable

Required Experience : Manager

Employment Type : Full‑Time

Experience : years

Vacancy : 1

The base pay for this position is

N / A

In specific locations the pay range may vary from the range posted.

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. 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.