Global Compliance Senior Auditor QA&RA

Req ID:  6954

Working Location: PENNSYLVANIA, CENTER VALLEY; Nationwide 

Workplace Flexibility: Field

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

he Global QA&RA Compliance Senior Auditor will be responsible for the support of the Global QMS Internal Audit Process and execution of global internal audits. Will lead Quality System audits throughout the organization to assess compliance of the quality system to applicable regulations, standards, and internal requirements. Serves as auditing subject matter expert and provide guidance on the interpretation of applicable regulations and standards. Will collaborate with stakeholders and partners to support the development and execution of a global internal audit program and supporting tools / resources that enhance internal audit capabilities.

Job Duties

  • Lead quality system audits throughout the global organization and all company locations that provide assurance of the compliance and effectiveness of the quality system.
  • Supports the establishment of a global internal audit program and execution of internal audit schedules.
  • Support the development and delivery of internal audit training activities throughout the organization.
  • Coordinate and support requests for directed audits, received from senior management and other customer/business partners.
  • Provides guidance on applicable regulatory requirements, their interpretation, and application.
  • Support external inspections and audit management for various sites, which will include site inspection/audit readiness and execution, as needed.
  • Lead or support special quality and compliance projects as requested, and perform other assigned duties, as needed.

Job Qualifications


  • Bachelor’s degree in Engineering discipline or equivalent
  • A minimum of 5 years of related professional experience in the medical device industry.
  • A minimum of 3 years’ experience of auditing quality systems in a medical device environment is required.
  • Requires background and familiarity with applicable regulatory requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA.
  • Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.
  • Experience writing, reviewing, and providing feedback on audit responses, is highly valued.
  • Experience working in a global organization and collaborating with multiple regions / company locations.
  • Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. Domestic and international travel up to 60 % of the time should be expected.



  • Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (R&D, Manufacturing, Supply Chain, Regulatory, Quality, Regulatory, etc…).
  • Proven, teamwork, collaboration and influencing skills.
  • Ability to work effectively in a fast paced and dynamic environment.
  • Working knowledge of problem-solving skills good statistical and analytical skills.
  • Strong written and verbal communication skills.
  • Proficient in the use of Information Technology.
  • Fluent in Japanese and / or English language (desired but not required).



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

The anticipated base pay range for this full-time position working at this location is $97,801.00 - $136,920.00 / 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 ncluding: 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


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.

Olympus requires all US new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.


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 || 

Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto

Job Segment: QA, Quality Assurance, Inspector, Engineer, Quality, Technology, Engineering