What are the responsibilities and job description for the Quality Management Systems Manager position at Olympus Corporation of the Americas?
Workplace Flexibility: Onsite
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.
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 Bartlett 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 Bartlett 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.
- Periodic travel to other facilities to support quality initiatives or training.
Preferred:
- Experience effectively completing CAPAs and NCRs) .
- Can teach Good Documentation practices .
- Strong knowledge of quality tools (Root Cause Analysis, Process Mapping)
- Strongly prefer Lean or Six Sigma skills and experience (DMAIC, Leading Kaizen events, Improving 5S/6S performance, FMEAs, Fishbone Analysis)
#LI-Onsite
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.
The anticipated base pay range for this full-time position working at this location is $100,022.00 - $140,032.00 / 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.
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.
Posting Notes: || United States (US) || California (US-CA) || San Jose ||
Salary : $100,022 - $140,032
