SENIOR QUALITY ENGINEER (ONSITE) JOB DETAILS | OLYMPUS CORPORATION OF THE AMERICAS

Working Location.
MINNESOTA, BROOKLYN PARK   Workplace Flexibility.
Onsite   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 of patient 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.
Learn more about Life at Olympus.
**Please note.
All correspondence will be sent from our Olympus domain (@Olympus.
om).
If you receive correspondence from an entity other than @Olympus.
om, it is likely not legitimate.
Job Description The Product Quality Engineer is responsible for the design, development and management of projects for legacy products.
The Product Quality Engineer provides organizational support with a focus on Design Quality activities.
Works with internal/external manufacturers providing finished products, services, components, and sub­assemblies to ensure compliance with company policies and procedures and medical device regulations.
The Product Quality Engineer will partner with Operations, R&D, Supply Chain and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.
Job Duties Drive the design & execution of Production Release Process project for components & finished devices Lead and implement complex projects including quality improvement initiatives.
Sets direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems.
Lead Process/Design Risk Analysis.
Provide leadership in understanding of the quality regulations to other disciplines.
Lead multiple product Design Control activities for new product development efforts.
Support Process/Design Validation Nerification activities and approach including software validation.
Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting.
Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing.
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Job Qualifications Required.
Bachelor's Degree in Engineering required.
Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment.
Strong working knowledge of technical problem solving via Six Sigma type tools to analyse, drive root cause, and solve problems.
Proven track record in Sustaining Engineering, support of commercialized products and Post Market Surveillance.
Strong working knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
Strong working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO , ISO , ISO , EUMDR and Human Factors.
Up to 10% domestic travel    Preferred.
Strong written and oral communication skills.
Ability to thrive in a fast-paced, dynamic and deadline-driven environment.
Well organized, flexible self-starter, team motivated and excellent at prioritizing and multi-tasking.
Skilled in presentation development and public speaking.
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 Comprehensive medical, dental, vision coverage effective on start date 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 Diversity Equity & Inclusion Initiatives including Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance   *US Only   **Center Valley, PA and Westborough, MA     Are you ready to be a part of our team?   Learn more about our benefit and incentives.
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 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 employees throughout locations in North and South America.
For more information, visit www.
lympusamerica.
om.
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 .
If your disability impairs your ability to email, you may call our HR Compliance Manager at -Olympus ().
Posting Notes.
|| United States (US) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA)