Field Corrective Action Principal Engineer

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

Field Corrective Action Principal Engineer

Working Location:Massachusetts, Westborough

Workplace Flexibility:Hybrid

For more than 100 years,Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Every day, we live by our philosophy,True to Life, by advancing medical technologies and elevating the standard ofpatient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

The Principal Quality Engineer is responsible for driving complex global field corrective action (FCA) or recalls projects to completion by effectively managing all aspects related to such initiatives within the Quality organization. Primarily focus will be on keeping FCA projects organized and on track to meet defined timelines while satisfying regulatory requirements and business strategy. This position requires a global outlook and the ability to integrate many different aspects of the organization, such as functions, departments, software platforms, etc. to ensure the project satisfies various stakeholders and areas of the business.

Job Duties

• Leads and participates in cross-technical FCA planning initiatives, such as defining scope, establishing an appropriate cross-functional team, creating FCA planning documentation, driving issues to resolution, escalating and mitigating risks, tracking, and reporting.
• Requests and processes medical device manufacturing and shipping data for upcoming FCAs, as well as data reconciliation activities to close FCAs.
• Provides expertise in the application of Quality Sciences including statistics, data analysis, problem solving and the creation of system solutions.
• Adheres to KPIs that influence the organization's directions, identifies gaps, current limitations, and challenges.
• Interfaces, collaborates, and/ or serves as a liaison with cross-functional teams, such as IT, Engineering, Operations, Finance, Security, Analytics, Legal, Comms, PMO, etc.
• Evaluates current state business processes and identify opportunities for increasing efficiency, reducing cost, etc. and quantify the problem through solution.
• Translates business use cases into technical specifications.
• Serves as a Subject matter expert (SME) for M365 productivity tools: PowerApps, Power BI, Power Automate, SharePoint.
• Effectively influences project team through written and verbal communication.
• Performs other duties as assigned.

Job Qualifications

Required:

• Bachelor’s degree in business administration, health policy, life sciences, engineering, or healthcare discipline. MBA or similar advanced degree preferred.
• Minimum 10 years leading projects with a focus on medical device Field Corrective Actions and data analytics.
• Minimum of 2 years of experience relating to supply chain / product distribution activities, inventory movement reconciliation and data processing.
• Proven ability to lead and manage cross- functional teams effectively communicate with all levels of management and drive effective change.
• Requires background and familiarity with global medical device regulations including 21 CFR 806.
• Strong Quality Science skills including demonstrated statistics application and problem solving.
• Excellent verbal and written communication skills demonstrated by ability to generate technical documents and ability to make presentations to middle and upper management.
• Proven Project Management skills with ability to manage cross functional team and produce results.
• Strong Interpersonal Skills, Ability to manage complexity, analytical, people management on a global basis, office 365 with advanced skills in MS Excel.
• Ability to travel up to 20% of time domestically and internationally.

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on

• Competitive salaries, annual bonus and 401(k)* with company match
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance*
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace

• Work-life integrated culture that supports an employee centric mindset
• Offers onsite, hybrid and field work environments
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs

The anticipated base pay range for this full-time position in this location is$122,362.00-$171,307.00/ year, plus potential for annual bonus(subject toplan eligibility andother requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.