Lead Quality Engineer - Post Market Surveillance
Lead Quality Engineer - Post Market Surveillance
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Job Description
JOB DESCRIPTION:
The Opportunity:
With a track record of innovation and development Abbotts 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-orientedPost Market Surveillance Leadto join our dynamic this pivotal role you will be responsible for overseeing 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 to senior leadership and cross-functional teams.
Key Responsibilities:
- Lead the development and execution of 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 teams input into the PMS and Periodic Safety Update Reports (PSUR) reports
- Prepare and submit PMS reports and PSURs
- Drive continuous improvement initiatives for the PMS and PRRC Process 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. Equally you will be a natural people leader with proven experience of 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 prioritise 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 which you can tailor to your own requirements. At Witney we also support our employees to live life to the fullest whether its 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/AIn 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
Employment Type
Full-Time
