Product Quality Assurance Manager
Product Quality Assurance Manager

Product Quality Assurance Manager

Dundee Full-Time 36000 - 60000 £ / year (est.) No home office possible
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Abbott Laboratories

At a Glance

  • Tasks: Lead quality assurance for innovative healthcare products and drive continuous improvement.
  • Company: Join Abbott, a global leader in health solutions with a diverse and inclusive culture.
  • Benefits: Enjoy competitive salary, private healthcare, pension scheme, and flexible benefits.
  • Why this job: Make a real impact in healthcare while developing your leadership skills.
  • Qualifications: Degree in life sciences and experience in regulated industries preferred.
  • Other info: Dynamic role with opportunities for career growth in a supportive environment.

The predicted salary is between 36000 - 60000 £ per year.

Product Quality Assurance Manager page is loaded## Product Quality Assurance Managerlocations: United Kingdom-Dundeetime type: Full timeposted on: Posted Todayjob requisition id: 31131892## **JOB DESCRIPTION:****Abbott**At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 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 You’ll Do**As the **Product Quality Assurance Manager** you will:* 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 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.**Required Qualifications / Profile*** Degree level or equivalent, preferably 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 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.**The base pay for this position is**N/AIn specific locations, the pay range may vary from the range posted.## **JOB FAMILY:**Operations Quality## **DIVISION:**CMI ARDx Cardiometabolic and Informatics## **LOCATION:**United Kingdom > Dundee : 17 Luna Place## **ADDITIONAL LOCATIONS:**## **WORK SHIFT:**Standard## **TRAVEL:**No## **MEDICAL SURVEILLANCE:**No## **SIGNIFICANT WORK ACTIVITIES:**Not Applicable #J-18808-Ljbffr

Product Quality Assurance Manager employer: Abbott Laboratories

Abbott is an exceptional employer that fosters a culture of innovation and accountability, providing employees with the opportunity to make a meaningful impact in the healthcare sector. Located in Dundee, the company offers competitive salaries, a comprehensive benefits package including private healthcare and a defined contribution pension scheme, as well as ample opportunities for professional growth and development within a supportive team environment. Join us at Abbott to shape your career while contributing to life-changing solutions that enhance health and well-being globally.
Abbott Laboratories

Contact Detail:

Abbott Laboratories Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Product Quality Assurance Manager

✨Tip Number 1

Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.

✨Tip Number 2

Prepare for interviews by researching Abbott and its products. Understand their values and how your experience aligns with their mission. This will help you stand out and show you're genuinely interested in the role.

✨Tip Number 3

Practice common interview questions and scenarios related to quality assurance. Use the STAR method (Situation, Task, Action, Result) to structure your answers and demonstrate your problem-solving skills effectively.

✨Tip Number 4

Don’t forget to follow up after your interview! A simple thank-you email can leave a lasting impression and shows your enthusiasm for the position. Plus, it keeps you on their radar as they make their decision.

We think you need these skills to ace Product Quality Assurance Manager

Leadership and Management Capabilities
Quality Record Audits
Regulatory Compliance (PRRC)
Root Cause Analysis (RCA)
Risk Assessments
Failure Mode Effect Analyses (FMEA)
Enterprise Resource Planning System (ERP)
Electronic Document Management Systems (EDMS)
ISO 13485:2016
Continuous Improvement Initiatives
Communication Skills
Team Development
Attention to Detail
Analytical Skills

Some tips for your application 🫡

Tailor Your CV: Make sure your CV is tailored to the Product Quality Assurance Manager role. Highlight relevant experience and skills that match the job description, especially in quality assurance and regulatory compliance.

Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your leadership and management capabilities, and how you've driven continuous improvement in past positions.

Showcase Your Technical Skills: Don’t forget to mention your technical understanding of ISO 13485:2016 and any experience with Root Cause Analysis tools. We want to see how you can contribute to our team with your expertise!

Apply Through Our Website: For the best chance of success, apply directly through our website. This ensures your application gets to the right people and shows us you're serious about joining our team at Abbott.

How to prepare for a job interview at Abbott Laboratories

✨Know Your Stuff

Make sure you brush up on your knowledge of ISO 13485:2016 and the specific quality assurance processes relevant to in-vitro diagnostics. Being able to discuss these topics confidently will show that you're not just familiar with the requirements, but that you can also apply them effectively.

✨Showcase Your Leadership Skills

As a Product Quality Assurance Manager, you'll need to demonstrate your leadership capabilities. Prepare examples of how you've successfully managed teams or projects in the past, focusing on how you fostered accountability and excellence within your team.

✨Prepare for Technical Questions

Expect questions about Root Cause Analysis (RCA) tools and Risk Management practices. Be ready to explain how you've used these tools in previous roles, and consider bringing along a case study or example to illustrate your experience.

✨Ask Insightful Questions

At the end of the interview, don’t forget to ask questions that show your interest in the role and the company. Inquire about the current challenges the QA team is facing or how Abbott fosters continuous improvement initiatives. This not only shows your enthusiasm but also helps you gauge if the company is the right fit for you.

Product Quality Assurance Manager
Abbott Laboratories
Location: Dundee
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