At a Glance
- Tasks: Lead post-market surveillance activities ensuring product safety and quality.
- Company: Join Abbott, a leader in innovative glucose monitoring systems.
- Benefits: Enjoy flexible benefits, private healthcare, and a vibrant workplace culture.
- Other info: Engage in fun activities like yoga, beekeeping, and community events.
- Why this job: Be part of a dynamic team driving continuous improvement and making a real impact.
- Qualifications: Degree in Science, Technology, or Engineering; regulatory experience preferred.
The predicted salary is between 43200 - 72000 £ per year.
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
#J-18808-LjbffrLead Quality Engineer - Post Market Surveillance in Witney employer: Abbott
Abbott's Diabetes Care business in Witney, Oxfordshire, is an exceptional employer that fosters a culture of innovation and employee well-being. With a strong focus on professional development, employees benefit from comprehensive training and mentorship opportunities, alongside a competitive benefits package that includes private healthcare and a flexible pension scheme. The vibrant work environment encourages participation in various wellness activities, making it a rewarding place to grow your career while contributing to life-changing medical advancements.
StudySmarter Expert Advice🤫
We think this is how you could land Lead Quality Engineer - Post Market Surveillance in Witney
✨Tip Number 1
Familiarise yourself with the latest regulations and standards related to post-market surveillance, particularly MDR and IVDR. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during discussions.
✨Tip Number 2
Network with professionals in the medical device industry, especially those involved in quality assurance and regulatory affairs. Engaging with these individuals can provide insights into the company culture and expectations, which can be invaluable during interviews.
✨Tip Number 3
Prepare to discuss specific examples of how you've led teams or projects in the past, particularly those that involved cross-functional collaboration. Highlighting your leadership style and ability to mentor others will resonate well with the hiring team.
✨Tip Number 4
Showcase your passion for continuous improvement by researching current trends and innovations in post-market surveillance. Being able to discuss these topics will illustrate your proactive approach and alignment with the company's goals.
We think you need these skills to ace Lead Quality Engineer - Post Market Surveillance in Witney
Some tips for your application 🫡
Understand the Role:Thoroughly read the job description for the Lead Quality Engineer - Post Market Surveillance position. Make sure you understand the key responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience:In your CV and cover letter, emphasise your experience in post-market surveillance, regulatory compliance, and team leadership. Use specific examples to demonstrate how your background aligns with the role's requirements.
Craft a Compelling Cover Letter:Write a personalised cover letter that showcases your passion for quality engineering and your understanding of Abbott's mission. Address how you can contribute to their post-market surveillance efforts and continuous improvement initiatives.
Proofread Your Application:Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for the role.
How to prepare for a job interview at Abbott
✨Understand the Regulatory Landscape
Familiarise yourself with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Being able to discuss these regulations confidently will demonstrate your expertise and show that you are well-prepared for the role.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams in the past. Highlight your experience in mentoring and developing team members, as this is crucial for the Post Market Surveillance Lead position.
✨Communicate Effectively
Practice articulating complex information clearly and concisely, especially when discussing post-market data and safety reports. Tailor your communication style to suit a director-level audience, as this will be key in your interactions with senior leadership.
✨Demonstrate Problem-Solving Abilities
Be ready to discuss specific instances where you've tackled challenges in quality assurance or post-market surveillance. Use the STAR method (Situation, Task, Action, Result) to structure your responses and showcase your logical approach to problem-solving.
