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

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

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