Lead Quality Engineer - Post Market Surveillance

Abbott; Witney; On-site; GBP 50,000 - 70,000; Full time

Job summary

Abbott's Diabetes Care business is looking for a Post Market Surveillance Lead to oversee compliance and post-launch activities. This role involves collaboration with senior leadership and various teams, utilizing regulatory knowledge and leadership skills to enhance product safety and quality while fostering employee development.

Benefits

Defined contribution pension scheme

Private healthcare

Life assurance

Flexible benefits scheme

Support for personal health activities (e.g., yoga)

Qualifications

• Educated to degree level (or equivalent), preferably in Science, Technology, or Engineering.
• Preferably with regulatory background, experience of MDR and IVDR.
• Exceptional communication skills for director-level audiences.

Responsibilities

• Lead the Post Market Surveillance (PMS) process compliance.
• Collate post-market data and prepare PMS reports.
• Supervise and mentor the PMS team.

Skills

Attention to detail

Problem-solving

Leadership

Communication

Education

Degree in Science, Technology, or Engineering

Job description

JOB DESCRIPTION:

The Opportunity:

With a track record of innovation and development, Abbott’s Diabetes Care business designs, develops, and manufactures leading-edge glucose monitoring systems for use in both home and hospital settings. We have a Global Centre of Excellence for Medical Devices based in Witney, Oxfordshire. The site manufactures significant volumes of test strips annually and has also been instrumental in the research, development, and now high-volume manufacture of the next-generation FreeStyle Libre Flash Glucose Monitoring System, launched in September 2014.

We are seeking a highly motivated and detail-oriented Post Market Surveillance Lead to join our dynamic team. In this pivotal role, you will oversee all post-market surveillance activities to ensure our products continue to meet safety, quality, and regulatory standards after launch. You will also play a key role in communicating with senior leadership and cross-functional teams.

Key Responsibilities:

• Lead the development and execution of the Post Market Surveillance (PMS) process in compliance with global regulatory requirements.
• Collate post-market data, including complaints, adverse events, and field safety actions.
• Coordinate cross-functional team input into PMS and Periodic Safety Update Reports (PSURs).
• Prepare and submit PMS reports and PSURs.
• Drive continuous improvement initiatives for the PMS and PRRC processes across the division.
• Supervise and mentor the PMS team, providing leadership, guidance, and support to ensure timely and high-quality surveillance activities.

About You:

The ideal candidate will be educated to degree level (or equivalent), preferably in a Science, Technology, or Engineering discipline. Preference is given to those with a regulatory background, with particular experience of MDR and IVDR.

You will excel in building strategic relationships across various locations, showcasing exceptional communication skills tailored for director-level audiences. You will be a natural people leader, with proven experience in developing, mentoring, and coaching your team to support employee growth and career development. Bringing an engaging and motivating style, and passion for leading change and continuous improvement projects, you will champion our business culture and evolving journey.

You must have excellent attention to detail, a logical and methodical approach to problem-solving, the ability to prioritize and manage projects, and the flexibility to adapt to changing circumstances or new demands.

What We Offer:

In addition to a competitive salary, Abbott offers a highly attractive benefits package, which includes a market-leading defined contribution pension scheme, private healthcare, life assurance, and a flexible benefits scheme that you can tailor to your own requirements. At Witney, we also support our employees to live life to the fullest—whether it’s joining our couch to 5k team, tending the allotments, learning to be a beekeeper, or dropping in for a yoga session, there is plenty for you to get involved in, should you wish!

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: CHMN Office of the Chairman

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