Principal Quality Engineer

Working Location: MINNESOTA, BROOKLYN PARK 

Workplace Flexibility: Field

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

 

**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

Engineers are indispensable to achieving our Mission. That’s why we empower you to bring the best of your experience to drive transformation in our service & repair quality organization. In this role as a Principal Quality Engineer, you will work as part of newly created global service & repair quality organization for projects related to creation, implementation and standardization of global processes , new product introduction to repair & service and sustaining engineering change management projects with cross-functional global teams. Mentor less experienced engineers within and across Olympus sites in best practices for the use of quality tools and methods.

Job Duties

• Provide input and lead activities related to design transfer planning, change management and ensure development projects are transitioned to repair & service facilities by defining success KPIs, ensuring risk measures and requirements are flowed down to repair sites, repair processes developed & qualified for transitioning from legal manufacturer across multiple repair sites and quality systems.
• Leads, supports, and guides the repair sites (as needed) to address quality issues and resolution using the best quality techniques and principles.
• Lead and collaborate with global repair & service sites to create, develop and maintain global quality standards and processes.
• Understands the interdependencies of FDA design controls, change controls and production and process controls to ensure processes are developed with the right level of control and maturity for repair and service sites.
• Drive strategic initiatives aimed at elevating product quality and compliance.
• Gain a deep understanding of how the system supports various processes within the repair & service quality organization. Leverage this knowledge to drive continuous improvement.
• Develop and implement innovative solutions to enhance quality outcomes.
• Develop, monitors process performance metrics, performs analysis and acts upon trends with minimal guidance.
• Serves as a mentor and advisor for the junior team in quality methodologies.

Job Qualifications

Required:

• Bachelor’s degree in engineering discipline or equivalent - Master’s Degree preferred.
• Minimum of 8 years related experience, preferably in the medical device industry related to operations/design/quality engineering.
• Viewed as an expert in the quality field.
• Leadership experience: 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 U.S. FDA QSR, requirements including ISO 9001, MDD and EU MDR, ISO 13485, 14971 and the ability to educate others on related subject matter.
• Will work with global teams, availability will include working across the associated time zones. International and domestic travel up to 15% of the time.

 

Preferred:

• Excellent verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations to middle and upper management.