Principal FCA Quality Engineer - Global Leader

Olympus Corporation; Boston (MA); Hybrid; USD 122,000 - 171,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

401(k) with company match

Medical/dental/vision coverage

Paid vacation and sick time

Job summary

Olympus Corporation seeks a Principal Quality Engineer in Massachusetts to drive global field corrective action (FCA) projects. You will manage timelines, regulatory alignment, and cross-functional collaboration to ensure FCA success.

The role requires 10+ years in medical device FCA/data analytics, strong Quality Science skills, and ability to lead diverse teams. Hybrid work with travel up to 20% internationally is available.

Qualifications

• Bachelor’s degree in a relevant field (business admin, health policy, life sciences, engineering or healthcare). MBA or similar advanced degree preferred.
• Minimum 10 years leading projects focused on medical device Field Corrective Actions and data analytics.
• Minimum 2 years experience in supply chain / product distribution activities, inventory movement reconciliation and data processing.
• Proven ability to lead cross-functional teams and communicate to all management levels; strong change leadership.

Responsibilities

• Lead FCA planning initiatives, define scope, assemble cross-functional teams, create planning docs and drive issue resolution.
• Request and process manufacturing/shipping data for FCAs and reconcile data.
• Apply Quality Sciences, including statistics, data analysis, problem solving and system solutions.
• Monitor KPIs, identify gaps and challenges, and propose improvements.
• Collaborate with IT, Engineering, Operations, Finance, Security, Analytics, Legal, PMO, etc.
• Translate business use cases into technical specifications and act as SME for MS 365 tools (PowerApps, Power BI, Power Automate, SharePoint).
• Travel up to 20% domestically and internationally.

Skills

Quality Science

Statistics

Problem Solving

Project Management

Communication

Interpersonal Skills

MS Excel

Education

Bachelor’s degree

MBA or advanced degree

Tools

PowerApps

Power BI

Power Automate

SharePoint

Job description

Olympus Corporation seeks a Principal Quality Engineer in Massachusetts to drive global field corrective action (FCA) projects. You will manage timelines, regulatory alignment, and cross-functional collaboration to ensure FCA success.

The role requires 10+ years in medical device FCA/data analytics, strong Quality Science skills, and ability to lead diverse teams. Hybrid work with travel up to 20% internationally is available.