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. ​ ​

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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 (https://www.olympusamerica.com/careers) .

Job Description

The Quality Manager is responsible for the direction and supervision of the site Quality Assurance and Production Quality team and their daily activities. This role is responsible for the overall site quality and ensuring Production and Process Quality during Manufacturing and post-market support.

Job Duties

• Direct management of site Quality Assurance and Production Quality teams

• Serves as site quality lead and Site Quality System Management Representative

• Lead and manage internal and external Quality Audits (including notified bodies and health authorities) and ensure related corrective action activities are completed in a robust and timely manner

• Support complaint handling and product investigations

• Identify and facilitate process and general improvements within the Quality System, embracing a culture of continuous improvement.

• Lead Quality Progress Meetings & Site Dashboard KPI efforts

• Compile and execute periodic Quality System Management Reviews with site leadership

• Responsible for site budgets, resourcing and planning

• Works collaboratively across all functions to resolve issues, communicate changes and to ensure the highest quality product is produced for our customers

• Communicate and train other employees on Quality processes and procedures

• Participate in maintenance and integration of the site quality management system by ensuring compliance to U.S. and international regulatory requirements for medical devices

• Other Quality Assurance responsibilities as assigned by Management

Job Qualifications

Required:

• BS degree or equivalent in an engineering or life science discipline.

• Minimum 5 years of professional experience or equivalent with training/education.

• Minimum of 2 years working in a regulated manufacturing environment required medical device industry.

• Strong working knowledge of production and process controls – including process development, process validation, sterile packaging and working in controlled environments

• Working knowledge of ISO 13485, 21 CFR Part 820, EUMDR, Medical Devices Directive, Canadian Medical Device Regulations, ISO 14971 and other applicable medical device industry US and international standards

• Experience with hosting front room, internal and external audit management

• Must be highly and effectively organized and be a flexible self-starter team-oriented and excellent at prioritization and multitasking

• Able to foster collaborative relationships across all lines of the Company

• Works with a passion for continuous improvement and quality

• Demonstrates the highest ethical standards actively promotes trust respect and integrity in all dealings both inside and outside the Company

• Travel: 10-15% mainly domestic

Preferred:

• MBA or other advanced degree preferred.

• Prior leadership / supervision experience is a plus.

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

• 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 (https://www.olympusamerica.com/careers/benefits-perks) .

The anticipated base pay range for this full-time position working at this location is $111,675.00 - $156,345.00 / year, plus potential for annual bonus (subject to plan eligibility and other 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 value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.

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 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).

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.

Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA)