Senior Manager Health Hazard Assessments (m/f/d)

Senior Manager Health Hazard Assessments (m/f/d)

Senior Manager Health Hazard Assessments (m/f/d)

Olympus Winter & Ibe GmbH (OWI)Chief Quality Officerfrom 01.03.2025, fulltime position, unlimited contract

Join Our Team as an Senior Health Hazard Assessment Manager!

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 in UK or Přerov, Czech Republic if needed.

Your Responsibilities

- Manage and supervise a global team of 2-4 HHA Senior and Principal Engineers, ensuring the successful completion of HHAs.

Your Responsibilities

- 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, including 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.

Your qualification

- Bachelor’s Degree in a technical or science-related field.
- At least 10 years of experience in the medical device or regulated industry, focusing on risk management, Health Hazard Assessments (HHAs), or corrective actions.
- A minimum of 5 years of experience in managing teams, including 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, with the ability to facilitate meetings and presentations.
- Excellent collaboration skills, with the ability to work across teams and cultures.
- Self-motivated with the ability to solve problems quickly and efficiently while maintaining a sense of urgency.

Your benefits

- 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 inhouse company gym

About Olympus

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.

About Olympus

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.
For more information, visit
www.olympus-europa.com
and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA .

Further information:

Valuing diverse perspectives and lifestyles is one of our core values. We would therefore like to encourage all people to apply – regardless of gender, restrictions, nationality, ethnic and social origin, religion, world view, age as well as sexual orientation and identity.

Further information:

Valuing diverse perspectives and lifestyles is one of our core values. We would therefore like to encourage all people to apply – regardless of gender, restrictions, nationality, ethnic and social origin, religion, world view, age as well as sexual orientation and identity.