At a Glance
- Tasks: Support quality systems by coordinating Field Safety Corrective Actions and maintaining accurate records.
- Company: Join a global leader in medical technology dedicated to improving lives for over 100 years.
- Benefits: Enjoy competitive salary, generous leave, private medical cover, and wellness support.
- Other info: Dynamic role with opportunities for growth and development in a supportive environment.
- Why this job: Kickstart your career in Quality and Regulatory Affairs with full training and real impact.
- Qualifications: GCSE English and Maths, strong organisational skills, and proficiency in Microsoft Office.
The predicted salary is between 31500 - 38500 Β£ per year.
FSCA Coordinator
A global leader in the medical device and technology industry, for more than 100 years, Olympus has focused on making people's lives healthier, safer, and more fulfilling.
Our products and solutions help to diagnose, prevent, and treat illnesses, further scientific research and keep people safe.
The post-holder will support the Senior Manager of Quality Systems, Commercial Quality & Patient Safety by providing administrative and coordination support for Field Safety Corrective Actions (FSCAs).
The role is responsible for maintaining accurate records, preparing reports, coordinating communications and supporting the tracking of corrective actions.
Full training will be provided, making this an excellent opportunity for someone looking to develop a career within Quality and Regulatory Affairs.
Responsibilities
- Implement and work to all applicable regulatory and quality requirements as stipulated within the Key Med Quality Manual, Quality Policy, and Quality Objectives.
- Implement and work to all applicable Health, Safety and Environmental requirements as stipulated within the HSE Manual, HSE Policies, and HSE Objectives.
- Maintain accurate records and databases relating to Field Safety Corrective Actions (FSCAs).
- Support the preparation and distribution of Field Safety Notices (FSNs) and related communications.
- Assist with tracking customer acknowledgements and corrective action responses.
- Update spreadsheets and databases to ensure information remains accurate and up to date.
- Produce routine reports on FSCA activities and response rates.
- Support the monitoring of shipping holds and assist with maintaining tracking logs.
- Escalate overdue actions or data discrepancies to the Senior Manager where required.
- Carry out other administrative or coordination duties to support the Quality team.
Qualifications
- GCSE (or equivalent) English and Mathematics (essential).
- Experience using Microsoft Office, particularly Excel and Outlook.
- Experience in a regulated environment is advantageous but not essential; full training will be provided.
- Strong organisational skills.
- Ability to take initiative.
- Comfortable using Microsoft Excel, Power Point and data management systems (essential).
Benefits
- Competitive salary.
- Generous annual leave entitlement.
- Private medical cover.
- Comprehensive company pension scheme.
- Annual health check with BUPA, funded by us.
- Employee Assistance Program to support health, mental and emotional wellbeing.
- Subsidised staff restaurant and free parking at HQ.
- Discounted gym and wellness memberships, cashback and discounts with major UK retailers.
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FSCA Co-Ordinator employer: OLYMPUS EUROPA SE & CO. KG
At Olympus, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation. Our commitment to employee growth is evident through comprehensive training programmes and mentorship opportunities, particularly for our Endotherapy Sales Leader role in the North of England. With a focus on operational excellence and customer satisfaction, we provide a rewarding environment where your contributions directly impact the healthcare landscape.
Contact Details:
OLYMPUS EUROPA SE & CO. KG Recruitment Team