Job Description

Working Location:  CALIFORNIA, SAN JOSE  

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. 

Job Description

Manage staff responsible for the maintenance of key quality management system activities including document and change controls, CAPA activities internal and external audits and special projects related to the maintenance and improvement of quality management systems at Olympus facilities in the U.S. manage and execute key Quality Projects. 

Job Duties

• Manage staff responsible for the maintenance of key quality management system activities including document and change controls, CAPA activities internal and external audits and special projects related to the maintenance and improvement of quality management systems at Olympus facilities in the U.S. manage and execute key Quality Projects.
• Support current and future quality management system development.
• Work with management and technical personnel from various departments within Olympus to understand existing systems and processes for purposes of identifying and documenting the most efficient workflow sequence needed to support the development maintenance and improvement of quality management systems at Olympus facilities within the U.S.
• Oversee CAPA activities related to the San Jose facilities, including but not limited to, status monitoring reporting follow-up verification and closure activities.
• Support CAPA activities at other facilities within the U.S. as needed.
• Manage the backroom at routine and periodic audit and assessment activities at the San Jose facilities including internal and external audits and inspections required to ensure that QSR / ISO compliance is maintained at all levels of the organization.
• Support these activities at other Olympus locations as needed.
• Oversee special projects related to the development maintenance and improvement of Quality Management Systems and production or Quality Processes at Olympus facilities in the U.S.
• Perform all other essential duties as directed.

Job Qualifications

Required:

• 4-year Bachelor of Science degree
• Minimum of 5 years supervisory or management experience in a regulated medical industry (Medical Devices, Pharmaceuticals, Biologics).
• Minimum of 8 years' experience in Quality Assurance.
• Strong leadership skills / experience required.
• Quality System experience required.
• Experience effectively completing CAPAs and NCRs).
• Can teach Good Documentation practices.
• Strong knowledge of quality tools (Root Cause Analysis, Process Mapping).
• Periodic travel to other facilities to support quality initiatives or training.

Preferred:

• Strongly prefer Lean or Six Sigma skills and experience (DMAIC).

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?

The anticipated base pay range for this full-time position working at this location is $124,873.00 - $174,822.00 / 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 .

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) || California (US-CA) || San Jose || Quality & Regulatory Affairs (QA/RA)  

Job Tags

Similar Jobs