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Global QARA Compliance Principal Auditor

Req ID:  6111

Working Location: Nationwide 


Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
Let’s inspire healthier lives, together.

Job Description

The Global QA&RA Compliance Principal 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.


* Serves as an Expert 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 Requirements



* Bachelor’s degree in Engineering discipline or equivalent.


* A minimum of 7 years of related professional experience and in medical device industry.


* A minimum of 5 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 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.




* Experience writing, reviewing, and providing feedback on audit responses, is highly valued.


* 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 leadership, 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).


** The anticipated compensation range for this position is $88,000 to $124,000 USD annually and the compensation offered will depend on the candidate’s qualifications.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.


Olympus requires all 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.


Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.


Olympus’ 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 overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit


Olympus…True To You. True To Society. True To LIFE.


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) || Pennsylvania (US-PA) || Center Valley || 

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

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