Global Field Corrective Action Principal Engineer (Hybrid)

Olympus America, Inc.; Westborough (MA); Hybrid; USD 122,000 - 171,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

401(k) with company match

Employee Assistance Program

Paid vacation and sick time

Paid parental leave

Job summary

Olympus America, Inc. is seeking a Field Corrective Action Principal Engineer in Westborough, MA with hybrid work options. You will drive global FCA initiatives, coordinate cross-functional teams, manage data and regulatory compliance, and apply quality science to complex recalls.

The role requires strong project management, communication, and ability to travel up to 20%. Responsibilities include planning, data requests, KPI tracking, and acting as SME for MS 365 tools while collaborating across

Qualifications

• Bachelor’s degree in business administration, health policy, life sciences, engineering, or healthcare discipline; MBA preferred.
• 10+ years leading projects with a focus on medical device Field Corrective Actions and data analytics.
• 2+ years in supply chain / product distribution activities, inventory movement reconciliation and data processing.
• Proven ability to lead cross-functional teams and communicate with all management levels.
• Familiarity with global medical device regulations including 21 CFR 806.
• Strong Quality Science skills with statistics application and problem solving.
• Excellent verbal and written communication; ability to present to middle and upper management.
• Proven Project Management skills to manage cross-functional teams and deliver results.
• Strong interpersonal skills and advanced MS Office 365, especially Excel.
• Willingness to travel up to 20% domestically and internationally.

Responsibilities

• Lead cross-technical FCA planning initiatives, define scope and cross-functional team.
• Request and reconcile medical device manufacturing/shipping data for FCAs.
• Provide expertise in quality sciences, statistics, problem solving.
• Adhere to KPIs, identify gaps and challenges.
• Collaborate with IT, Engineering, Operations, Finance, Legal and others.
• Evaluate processes to increase efficiency and reduce costs.
• Translate business use cases into technical specifications.
• Serve as SME for PowerApps, Power BI, Power Automate, SharePoint.
• Influence project teams through clear communication.
• Perform other duties as assigned.

Skills

Data analytics

Statistics

Project management

Cross-functional leadership

Communication

Excel

Education

Bachelor’s degree in relevant field

MBA or similar advanced degree

Tools

Power BI

Power Apps

Power Automate

SharePoint

MS Excel

Job description

Olympus America, Inc. is seeking a Field Corrective Action Principal Engineer in Westborough, MA with hybrid work options. You will drive global FCA initiatives, coordinate cross-functional teams, manage data and regulatory compliance, and apply quality science to complex recalls.

The role requires strong project management, communication, and ability to travel up to 20%. Responsibilities include planning, data requests, KPI tracking, and acting as SME for MS 365 tools while collaborating across