Remote Senior Health Hazard Assessment Lead | Medical Devices

Olympus America, Inc.; False Pass (AK); Remote; USD 87,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

401(k) match

Medical coverage

Paid vacation and sick time

Parental leave

On-site daycare, cafe, fitness center

Volunteer match program

Job summary

Olympus Corporation of the Americas seeks a Health Hazard Assessment (HHA) lead to develop data-driven HHAs with robust analysis and conclusions. You will drive timely completion and ensure compliance across global operations, collaborating with Risk Management and cross-functional teams.

You will guide project teams, present to review boards, and stay current with FDA QSRs, ISO standards, and post-market activities while supporting internal and regulatory inspections.

Qualifications

• Bachelor's degree or equivalent in a technical or science-related field is required.
• Minimum of 5 years' experience in finished medical device or related regulated industry with manufacturing processes, operational excellence, quality systems, and continuous improvement activities required.
• Ability to influence across multiple sites and manage multiple projects.
• Excellent verbal and written communication skills, including public speaking and facilitation.

Responsibilities

• Leads a HHA project team to write and manage a HHA through to completion.
• Ensure HHA target completion is achieved.
• Works to meet key performance indicators.
• Prepares HHA supporting materials and presents HHA to review board as needed.
• Responds to requests for HHA amendments in a timely manner.
• Maintain knowledge of industry best practices and regulatory requirements in Risk Management, HHAs and related areas.

Skills

Cross-functional collaboration

Project management

Communication skills

Time management

Problem solving

Influencing across sites

Education

Bachelor's degree in technical or science field

Job description

Olympus Corporation of the Americas seeks a Health Hazard Assessment (HHA) lead to develop data-driven HHAs with robust analysis and conclusions. You will drive timely completion and ensure compliance across global operations, collaborating with Risk Management and cross-functional teams.

You will guide project teams, present to review boards, and stay current with FDA QSRs, ISO standards, and post-market activities while supporting internal and regulatory inspections.