Ihre Aufgaben
- 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.
Ihre Qualifikationen
- 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.
Ihre Vorteile
-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