Olympus Corporation of the Americas · 2 days ago
Senior Engineer, Health Hazard Assessment
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Medical Device
Insider Connection @Olympus Corporation of the Americas
Responsibilities
Support the development, writing, and completion of Health Hazard Assessment (HHAs) across Olympus globally.
Lead a HHA project team to write and manage HHAs through to completion.
Ensure HHA target completion is achieved and meet key performance indicators.
Prepare HHA supporting materials and present HHAs to review boards as needed.
Maintain current knowledge of industry best practices, regulatory requirements, and Olympus operations.
Collaborate with global/regional leaders and interact with Legal and Compliance.
Support HHAs in internal and regulatory inspections.
Qualification
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Required
Bachelor’s Degree or equivalent in a technical or science-related field is required.
Minimum 3 to 5 years’ experience working in finished medical device or related regulated industry with manufacturing processes, operational excellence, quality systems, and continuous improvement activities required.
Flexible working hours across multiple time zones, due to the Global nature of this role.
Preferred
Knowledge of Risk Management practices, Corrective and Preventative Actions and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971 & 21 CFR 820 is preferred.
Ability to influence across multiple sites.
Must be self-motivated with a strong sense of urgency to solve issues.
Ability to consistently deliver on required activities and meet assigned deadlines.
Demonstrated ability to manage and complete multiple projects and assigned objectives.
Prior experience leading cross-functional teams.
Excellent verbal and written communication skills, including public speaking and facilitation.
Excellent interpersonal skills and experience working with different personalities, cultures, and levels of management.
Benefits
Competitive salaries
Annual bonus
401(k) with company match
Comprehensive Medical, Dental, Vision coverage effective on start date
24/7 Employee Assistance Program
Free virtual live and on-demand wellness classes
Work-life balance supportive culture with hybrid and remote roles
12 Paid Holidays
Educational Assistance
Parental Leave and Adoption Assistance
Volunteering and charitable donation match programs
Diversity & Inclusion Programs including Colleague Affinity Networks
On-Site Child Daycare
Café
Fitness Center
Company
Olympus Corporation of the Americas
At Olympus, we put a lot of good back into the world, and what we do, really matters.
Funding
Current Stage
Late StageLeadership Team
Recent News
2023-10-25
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