Principal Quality Engineer

Working Location: NATIONWIDE 

Workplace Flexibility: Field

 

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

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

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

 

 

Job Description

The Principal Quality Engineer is responsible for planning and executing global Market Quality key initiatives such as process and solution designs in close collaboration with other Complaint Handling teams in all applicable regions (Japan, EMEA etc.).

 

This position may lead a project team of SMEs in the execution of such initiatives to ensure a design and execution in compliance with all applicable global regulations and laws. This position may also be responsible for CAPA ownership and execution.

Job Duties

• Responsible and accountable for complaint process and solution design planning and execution across all applicable regions (Japan, EMEA, etc.)
• Acting as a solution architect at the interface between MDR reporting, complaint investigation, Design Assurance and Post Market Surveillance
• Responsible for large budget projects and initiatives
• Create, review, and approve release of changes to QMS documentation. Coordinate with other functions and sites to ensure timely and accurate completion and efficient change processing.
• Ensures that the market quality processes are standardized throughout the business and ensures that they are implemented consistently and correctly.
• Identifies areas of focus through data driven trending and brings solutions to management.
• Act as Audit Finding coordinator.
• Provides resident expertise in the application of Quality Sciences including, statistics, data analysis, problem solving and the creation of system solutions for Quality System issues.
• All Other Essential Duties as assigned

Job Qualifications

Required:

• Bachelor of Science, medical, engineering, or scientific discipline
• Minimum of 10 years’ experience in a drug/device manufacturer/distributor with strong concentration in domestic (USA) and International Quality System Regulations (QSR ) compliance and quality assurance.
• Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses. Demonstrated experience in developing and leading a top performing Quality team is required.
• Competent understanding of medical device regulations both domestic and international with specific expertise in; Regulator Inspections, Complaints and Regulatory reporting, and Corrective and Preventive Actions (CAPA).
• Competent with Microsoft Office 365 Suite including Power BI, Apple iOS, Adobe, DocuSign, and Windows platforms.
• Up to 25% domestic travel, if not co-located with an Olympus manufacturing and/or service center.

Why join Olympus?

 

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