Quality Engineer Health Hazard Assessments (m/f/d)

Quality Engineer Health Hazard Assessments (m/f/d)

Quality Engineer 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 Quality Engineer HHA!

Take the lead in driving Health Hazard Assessments (HHAs) across Olympus on a global scale. In this role, you will write data-driven, evidence-based HHAs, ensuring robust issue analysis and justified conclusions. Collaborate with cross-functional teams, meet key performance indicators, and support Olympus’ safety and compliance efforts. If you have a passion for risk management and are ready to contribute to the safety of our products, this is your opportunity!

The position is preferably based in our EMEA HQ inHamburg, but it can also be located in Coimbra, Portugal, Southend-on-Sea inUK or Přerov, Czech Republic.

Your Responsibilities

- Lead HHA project teams to write, manage, and ensure the completion of Health Hazard Assessments.

Your Responsibilities

- Lead HHA project teams to write, manage, and ensure the completion of Health Hazard Assessments.
- Ensure that HHA completion targets are met by adhering to established timelines and performance indicators.
- Prepare supporting materials for HHAs and present them to the HHA/Field Corrective Action review board as necessary. Respond to requests for HHA amendments in a timely and efficient manner.
- Stay up-to-date with industry best practices and regulatory requirements, including Olympus’ operations in Risk Management, Field Actions, complaint handling, adverse event reporting, CAPA, and Post Market Surveillance.
- Collaborate with global and regional leaders on relevant HHAs and work with Legal and Compliance teams as needed.
- Provide expert support for HHAs in internal and regulatory inspections.

Your qualification

- Bachelor's Degree in a technical or science-related field.
- At least 5 years of experience in the medical device or regulated industry, with expertise in manufacturing processes, quality systems, and continuous improvement.
- Strong knowledge of Risk Management practices and regulatory standards (e.g., FDA QSRs, ISO 13485, ISO 14971, 21 CFR 820).
- Ability to collaborate across sites and lead cross-functional teams effectively.
- Self-motivated with a strong sense of urgency to resolve issues and meet deadlines.
- Proven experience managing multiple projects to completion.
- Excellent communication skills, including public speaking and facilitation.
- Flexibility to work across multiple time zones due to the global nature of the role.

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.