Product Quality Assurance Manager at Abbott

Dundee, Scotland, United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Diagnostics, Medical Devices, Healthcare, PharmaceuticalsIndustries

Requirements

Degree level or equivalent, preferably in a life science subject area
Experience in 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 PowerPoint

Responsibilities

Provide strategic oversight of independent approval of raw materials, intermediates, and finished products via Quality Record Audits and physical inspections
Provide strategic oversight of product design, process, and facility changes through the Design Quality Group
Provide strategic oversight of complaint intake, reportability assessment, investigation, and resolution via the Product Support Team
Provide strategic oversight of nonconformance and CAPA processes
Provide strategic oversight of Supplier Quality Assurance activities
Act as Depute 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

Skills

Key technologies and capabilities for this role

Quality AssuranceRegulatory CompliancePRRCCAPANonconformance ManagementSupplier Quality AssuranceAudit ManagementComplaint InvestigationContinuous ImprovementTeam LeadershipPerformance ReviewsIVD ManufacturingDesign QualityRaw Material ApprovalProcess Changes

Questions & Answers

Common questions about this position

What benefits are offered for this role?

Abbott offers a competitive range of benefits including excellent salaries, a class-leading defined contribution pension scheme, and private healthcare.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What qualifications and skills are required for the Product Quality Assurance Manager role?

Required qualifications include a degree level or equivalent, preferably in a life science subject area, experience in a regulated industry, demonstrable leadership capabilities, understanding of ISO 13485:2016, root cause analysis tools like A3/DMAIC, risk assessments including FMEA, ERP and EDMS experience, and proficiency in MS Word, Excel, and PowerPoint.

What is the company culture like at Abbott?

Abbott fosters diverse ideas, perspectives, and expertise to create life-changing solutions, and promotes a culture of accountability, ownership, and excellence within the team.

What makes a strong candidate for this Product Quality Assurance Manager position?

A strong candidate will have a life science degree, leadership experience in a regulated industry like IVD manufacturing, deep knowledge of ISO 13485:2016, RCA tools, risk management, and systems like ERP/EDMS, along with proficiency in Microsoft Office tools.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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