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.
Within the Olympus Corporation, Olympus Surgical Technologies Europe (OSTE) is the global competence center for development, production and repair services for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of about 3,600 employees at 14 locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical technology and therapy and offers a full range of the most modern endoscopic applications from single products to procedure-oriented system solutions.
Join our team as a Senior Health Hazard Assessment Manager (m/f/d)!
Take the lead in a dynamic, global role where you'll manage a team of engineers to ensure the timely and thorough completion of Health Hazard Assessments (HHAs) across Olympus. Collaborate with cross-functional teams worldwide, provide expert post-market risk management and step in as a delegate for the HHA Chair when needed. Play a key role in upholding Olympus' commitment to safety and regulatory compliance. If you're ready to make an impact on a global scale, this is the opportunity for you!
The position is preferably based in EMEA HQ in Hamburg, but it can also be located in other Olympus locations as Coimbra, Portugal, Southend-on-Sea, UK, or Prerov, Czech Republic, if needed.
- Manage and supervise a global team of 2–4 HHA Senior and Principal Engineers, ensuring the successful completion of HHAs
- Oversee recruitment, training and performance management of HHA engineers to ensure they meet team and organizational goals
- Collaborate with cross-functional teams such as quality, regulatory and engineering to track and ensure the timely completion of HHAs
- Ensure that HHA target completion dates are met, addressing any delays or issues proactively
- Contribute to process documentation, incl. procedures, work instructions and templates, to improve the effectiveness of the HHA process
- Act as a delegate for the HHA Chair, stepping in as needed for decision-making and team discussions
- Provide post-market risk management expertise to support the HHA team in evaluating and mitigating product risks
- Lead and facilitate corrective actions (CAPAs) and non-conformance (NC) reports as necessary to resolve issues within the HHA process
- Bachelor's degree in a technical or science-related field
- Long-standing experience in the medical device or regulated industry, focusing on risk management, Health Hazard Assessments (HHAs) or corrective actions
- Long-standing experience in managing teams, incl. overseeing performance and workload distribution
- In-depth knowledge of FDA QSRs, ISO 13485, ISO 14971 and 21 CFR 820 regulations
- Proven ability to manage multiple projects simultaneously and meet deadlines
- Strong verbal and written communication skills and ability to facilitate meetings and presentations
- Excellent collaboration skills and ability to work across teams and cultures
- Self-motivation and ability to solve problems quickly and efficiently while maintaining a sense of urgency
- 30 days of annual leave
- Up to 60% mobile work possible + flexible work time model with overtime compensation
- Holiday and Christmas bonuses
- Corporate benefits discounts for employees
- Comprehensive company pension scheme and capital-forming benefits
- Company restaurant with live cooking and healthy food (subsidized)
- Employee Assistance Program of famPLUS to support your health, mental and emotional well-being
- Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
- Various subsidized company sports groups and access to the in-house company gym
GIMED1_DE
