Senior Manager Global FCA Projects (m/f/d)

Ihre Aufgaben

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

Ihre Qualifikationen

• Bachelor’s degree in business, sciences, quality management, or related field, or equivalent professional experience.
• 8+ years of experience working within medical device industry
• 5 years in design assurance or post-market quality function preferred.
• Experience interacting with regulatory authorities
• Proven leadership experience in cross-functional teams within a hybrid setup.
• Lean Sigma green belt or higher preferred.
• Excellent verbal and written communication skills in a business fluent 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 would be in 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

Ihre Vorteile

• Flexible working hours, remote work possible (up to 60%)
• 30 days of holidays per year
• Modern office and an 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 an inhouse company gym
• Employee Assistance Program to support your health, mental and emotional well-being
• A 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
Vor 4 Tagen