Job Information
Olympus Corporation of the Americas Principal Quality Engineer in Brooklyn Park, Minnesota
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.
Proven Project Management skills, with ability to produce results.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization and/or guidance exists.
Ability to work across matrixed structure and with global teams.
Demonstrated ability to drive organizational change and continuous improvement
Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected
Problem Solving, Technical Aptitude, Attention to Detail, Solution Oriented, Effective Verbal and Written Communicator, Quality Engineering Disciplines, Quality Control Disciplines, Quality Systems Disciplines and Strategic Leadership
Why join Olympus?
Here, people matter—our health, our happiness, and our lives.
Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive Medical, Dental, Visions coverage effective on start date
24/7 Employee Assistance Program
Free virtual live and on-demand wellness classes
Work-life balance supportive culture with hybrid and remote roles
12 Paid Holidays
Educational Assistance
Parental Leave and Adoption Assistance
Volunteering and charitable donation match programs
Diversity & Inclusion Programs including Colleague Affinity Networks
On-Site Child Daycare, Café, Fitness Center**
*US Only
**Limited locations
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks .
About us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
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 .
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
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.
Applicants with Disabilities: As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA)