Quality Assurance Engineer 3 - Medical Device Manufacturing

Abbott; Witney; On-site; GBP 80,000 - 100,000; Full time

Job summary

A global healthcare company is seeking an experienced Operations QA Engineer III in Witney to support New Product Introduction within their Quality Assurance & Compliance Group. The ideal candidate will have a proven track record in quality roles in regulated environments, strong problem-solving ability, and leadership experience. This position offers opportunities for structured career development and includes competitive benefits and a positive work environment.

Benefits

Competitive salaries

Defined contribution pension scheme

Share ownership scheme

Private healthcare

Life assurance

Flexible benefits scheme

Onsite allotments

Couch to 5k campaigns

Bee keeping

Yoga

Other initiatives

Qualifications

• Proven experience in leading and developing teams within a quality-related role.
• Track record of achievements in a regulated environment such as medical devices or pharmaceutical manufacturing.

Responsibilities

• Oversee processing of validation and development lots through manufacturing area.
• Investigate and document Quality issues; communicate as required.
• Support monitoring and compliance of Quality Management System.
• Plan and conduct inspections as per the inspection plan.
• Lead team through daily issue resolution and workload prioritization.

Skills

Problem solving

Good communication skills

Leadership

Experience with New Product Introduction

Education

Degree in scientific, engineering or associated field

Job description

Overview

JOB DESCRIPTION: 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. 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.

World Leader in Glucose Monitoring, Abbott Diabetes Care designs, develops and manufactures glucose monitoring systems for use in both home and hospital settings. We have a Centre of Excellence in Witney for the development and manufacture of electrodes and biosensors used by patients and healthcare professionals for the day-to-day management of diabetes. The site has been instrumental in the research, development and manufacture of the FreeStyle Libre Flash Glucose Monitoring System as well as exciting developments in the Libre family including FreeStyle Libre 2, FreeStyle Libre 3 and the Libre Sense system. We are passionate about doing work that improves the quality of people’s lives.

To support the continued volume manufacture of our latest product, we have an exciting opportunity for an experienced Quality Engineer to join our Quality Assurance & Compliance Group in the role of Operations QA Engineer III, with a particular focus in supporting New Product Introduction (NPI).

The QAC teamwork closely with departments such as Operations/Manufacturing, R&D, Technical, Engineering, and Regulatory Affairs to achieve project goals relating to the development, manufacture and delivery of quality and compliant products on time, in full and cost effectively.

This role offers the successful candidate the opportunity to develop their QA knowledge within a fast paced, dynamic and evolving environment. In addition, this role will take leadership responsibility of a small team across both shift and core days patterns.

The key responsibilities in this role are:

Responsibilities

• Overseeing the processing of validation and development lots through the manufacturing area in alignment with established plans/protocols
• Investigate, document and remediate Quality issues that arise; communicate and escalate as required
• Deliver the quality message around site through team training, presentations and tool box talks
• Support the monitoring and compliance of the Quality Management System as it applies to site Operations
• Plan, conduct and review inspections for all areas as per the inspection plan. Communicate findings and work with areas leads to implement corrective actions
• Support Operations to make Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring and packaging
• Champion projects that enhance and promote the effectiveness and efficiency of the quality system and product quality
• Promote a “right first time” approach to Quality Records by ensuring accountability for functional responsibilities
• Lead your team through day to day issue resolution, workload prioritisation, problem solving, and career development

Qualifications

This is an exciting opportunity to join a high-achieving team that offers structured career development opportunities within a state-of-the-art manufacturing facility working on an exciting and complex new product.

Problem solving is a key feature of this position along with the need for good communication skills, and the proven experience of leading and developing teams. To be successful, you will need to be a decisive and solutions-orientated individual with a track record of successful achievements and accomplishments in a quality-related role in a regulated environment (such as medical devices, pharmaceutical or healthcare manufacturing), and bring experience of working with New Product Introduction projects. You will be degree qualified in a scientific, engineering or associated field.

Benefits

As you’d expect from an innovative global health care company, we offer an excellent range of benefits including competitive salaries, a defined contribution pension scheme, share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme. Here at Witney, we also like to help our employees live life to the fullest, and therefore we offer a range of optional initiatives for you to get involved in, including onsite allotments, couch to 5k campaigns, bee keeping, yoga and more!

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: ADC Diabetes Care LOCATION: United Kingdom > Witney : Production Facility ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable