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Director, Global QARA Compliance, Internal Audit

Req ID:  5845



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

* Establishment of a Global Quality and Compliance organization.


* Completion of Global Quality and Regulatory transformation initiatives and organization goals.


* Development and implementation of global compliance audit program.


* Develop systems and processes to support global execution of the Quality system, specifically the development and implementation of Global Internal Audit Quality System policies, procedures, and programs. Providing assurance of the compliance of the organization with FDA 21 CFR, Part 820, ISO 13485, and all other applicable global regulatory requirements. 


* Serves as the Global Internal Audit Quality System Process Steward, providing assurance of the effectiveness and continuous improvement of the Global Internal Audit Process and supporting programs. 


* Quality Leader providing training and mentoring to the organization in all quality and compliance matters supporting the development of talent and competencies.

Job Duties

* Develops and implements the Global Internal Audit Quality System policies, procedures, and programs.  Designated as the Global Internal Audit Quality Systems Process Steward. 


* Development and maintenance of Global QA&RA Compliance and OSTA site internal audit schedules.  Responsible for planning, conducting, and reporting audits of entities engaged in quality systems and clinical trials activities to assure compliance with applicable global regulatory requirements and company policies and procedures.


* Development and implementation of new tools and metrics that measure progress of internal audit schedules and audit outcomes.  Identifies, accesses, and analyzes data that have impact on the company’s compliance to overall quality systems.  Tracks, trends, and analyzes internal audit findings, corrective actions, and remidiations. Strategically leverages such information to proactively design a robust internal audit program. Able to make recommendations based on areas of highest compliance risk.


* Develop and deliver Compliance monitoring scorecards and communications to Executive Leadership for real time reporting of internal audit outcomes.


* Development and implementation of Global Internal Auditor qualification requirements, capabilities, and auditing techniques training programs.


* Leads team and Global Internal Audit Communities of Practice in process implementation and continuous improvement efforts.


* Serves as the Olympus subject matter expert for the Global Internal Audit Quality System Process. 


* Serves as an internal consultant by providing guidance and meaningful interpretations of applicable regulations to quality and clinical teams.


* Provides guidance and approval regarding quality strategies and approaches.


* Development and implementation of Global internal auditor qualification requirements, capabilities, and auditing techniques training programs.

Job Requirements



* Bachelor’s degree or equivalent.


* Minimum of 10 years related experience and in medical device industry.


* Requires background and strong familiarity with applicable regulatory requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. 


* 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 40 % of the time should be expected.




* Experience with applicable Regulatory Agency or Authority is preferred.


* Very strong risk / auditor skills – critical to evaluate remediation of issues and management’s action plans.


* Leadership and interpersonal skills to develop and manage good working relationships with internal departments (R&D, Manufacturing, Supply Chain, Regulatory, Quality, Regulatory, etc…)


* Ability to work effectively in a fast paced and dynamic environment.


* Working knowledge of problem-solving skills good statistical and analytical skills. Proven success in driving cultural change.


* Proven Management and leadership skills; ability to lead and manage cross functional teams and develop talent.


* Strong written and verbal communication skills.


* Proficient in the use of Information Technology.

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: QA, Quality Assurance, Manager, Quality, Technology, Management

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