Lead Auditor

Abbott; Witney; On-site; GBP 40,000 - 70,000

Job description

JOB DESCRIPTION: Job Title: Lead Auditor Location: Witney, United Kingdom

THE OPPORTUNITY

With a track record of innovation and development, Abbott designs, develops, and manufactures leading-edge medical devices. 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 manufacture of the next generation FreeStyle Libre Flash Glucose Monitoring System, launched in September 2014.

We have an opportunity for a Lead Auditor to support and guide assigned internal audits, supplier audits, and external audit processes. This position will manage and support compliance gap management activities, including regulatory and standards tracking and other compliance gap management activities. You will be part of a highly collaborative international team, given autonomy and freedom to make impactful decisions.

MAIN RESPONSIBILITIES

• Lead and support assigned internal, clinical, and supplier audits to ensure timely closure of audit cycles.
• Support audit readiness activities for external audits, including training staff and providing guidance in preparation for external audits.
• Support compliance gap management activities, such as compliance risk management.
• Identify risks to the division and propose resolutions to address compliance gaps.
• Strategize and prioritize compliance gaps and track them to closure.
• Provide guidance to SMEs in closing compliance gaps.
• Assist in the management of the near-miss program.
• Track regulations and industry standards revisions, evaluate their impact, and ensure compliance.
• Prepare, review, and investigate metrics data.
• Promote awareness and understanding of quality and compliance within the division. Provide training to increase compliance awareness.
• Participate in and manage compliance initiatives and other assigned projects.

QUALIFICATIONS

Education: Bachelor's Degree in a technical field such as Science or Engineering, or an equivalent combination of education and work experience.

Experience:

• ISO 13485 - certified in medical devices.
• Experience in medical devices or pharmaceuticals.
• Experience in quality assurance, internal auditing, quality compliance management, or related fields.

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 and life assurance, and a flexible benefits scheme which 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 engage with as and when you wish!

ABOUT OUR DIABETES CARE DIVISION

At Abbott, we believe in the power of health. For over 135 years, we've been helping people reach their potential because better health allows individuals and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create innovative solutions across the spectrum of health, 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 revolutionary technologies in healthcare, helping people live their best lives through better health.