Quality Systems Analyst

Req ID: 9215

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.

Learn more about Life at Olympus.

**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

This position is responsible for the continued development and maintenance of Quality Assurance systems in order to ensure compliance with the requirements of 21 CFR Part 82 Quality System Regulation(QSR), ISO 13485, and other quality standards. This function under general supervision works with all OSTA departments to establish and maintain robust processes systems and procedures designed to support all aspects of the OSTA Quality Management System and general continuous improvement activities.

Job Duties

Assist with routine and periodic internal and external audits to ensure QSR / ISO compliance is maintained at all levels of the organization.
Review incoming audit responses to ensure they are consistent with policy.
Support all departments on the successful execution of the internal audit schedule and policy.
Provide quality system support during external audits and inspections.
Support Document and Change Control processes and systems including the ongoing maintenance and improvement of databases reports and ancillary systems.
Support CAPA and Audit processes and systems including the ongoing maintenance and improvement of databases reports and ancillary systems.
Act as a CAPA mentor for CAPA Owners.
Maintain and improve Quality Management System processes procedures and systems to ensure continued compliance with documented requirements and standards.
Support continuous improvement projects related to the development maintenance and improvement of Olympus quality management systems.
Support quality system data collection and provide regular reports to management on quality system topics such as Audit status, CAPAs, and Change Control.
Develop curriculum and provide training and support for established OSTA quality systems.
Perform all other duties as required.

Job Qualifications

Required:

High School diploma required. Bachelor’s degree preferred.
Minimum 3-5 years experience working with quality systems preferably in a medical device company.
Must possess excellent organizational skills with the ability to prioritize workload.
Must possess strong computer skills including experience working with web sites and databases.
Must have Quality System auditing experience.
Must possess good written and verbal communication skills.
Must be flexible self-motivated analytical detail-oriented and practical.
Familiarity with basic database and web site management.

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.

The anticipated base pay range for this full-time position working at this location is $74,999.00 - $101,249.00 / 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.

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

Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto
Job Segment: Systems Analyst, CAPA, QA, Quality Assurance, Technology, Management, Quality

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