Job Description
At Olympus, we are committed to our purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Olympus Europa, headquartered in Hamburg, Germany, serves the EMEA (Europe, Middle East, Africa) region and employs 6,900 people in 31 countries. For more information, visit our website.
As the Senior Manager Global FCA Projects, you will lead and oversee all aspects of field corrective actions (FCAs) from initiation to completion. Your role involves guiding cross-functional teams to create comprehensive global plans that mitigate risks, comply with regulations and meet customer needs. This position requires strong analytical, problem-solving and communication skills to handle complex quality issues and ensure smooth execution of recall strategies.
Tasks
- Lead global FCA teams in planning and implementing FCA decisions
- Develop detailed global FCA plans, including timelines, milestones, resources and activities
- Monitor FCA progress, addressing issues promptly to meet deadlines and compliance requirements
- Ensure project deliverables through effective stakeholder collaboration
- Draft quality customer notification letters, safety advisories and field safety notices
- Communicate effectively with all organizational levels to align FCA plans
- Support Regional Leads in timely regulatory inquiries
- Assist in internal audits, notified body and FDA inspections
- Supervise and manage a Project Manager for timely execution of FCA projects
- Bachelor's degree in Business, Sciences, Quality Management or related field or equivalent professional experience
- Long-standing experience working within the medical device industry
- Several years of experience in design assurance or post-market quality function preferred
- Experience interacting with regulatory authorities
- Proven leadership experience in cross-functional teams within a hybrid set-up
- Lean Sigma green belt or higher preferred
- Excellent verbal and written communication skills in business English
- Strong ability in stakeholder management to coach and influence others with a high focus on problem-solving and an analytical mindset
Additional Considerations
- Flexibility for overtime or on-call work and willingness to travel as needed
- Preferred location EMEA HQ Hamburg, but remote work possible from any Olympus EMEA location as the team would be located across the globe
Join our team to drive impactful FCA projects and make a significant difference in global quality management!
Your Competencies
The interview will be competence-based and the following competencies will be assessed:
- Patient focus
- Strategic and innovative mindset
- Integrity
- Impact
- Collaboration
- Flexible working hours, remote work possible (up to 60%)
- 30 days of holiday per year
- Modern office and inspiring working environment
- Employee restaurant with live cooking and healthy food (subsidized)
- Public transport ticket (100% subsidized) or free parking space
- Company sport groups and in-house company gym
- Employee Assistance Program to support your health, mental and emotional well-being
- Comprehensive company pension scheme
- Company medical officer and vaccination offers
- Childcare through our ‘Buttje & Deern' partner
- Company car, also for private use (for field staff only)
- Bike leasing