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Executive Director, Quality - Americas

Req ID:  5833



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 Executive Director, Quality – Americas, is responsible for quality operations at the Company’s manufacturing sites including management of site-based quality teams. Serve as the subject matter expert on CGMP requirements, ensuring that systems and procedures are in accordance with applicable laws and regulations. The Executive Director, Quality develops strategic and operational plans to ensure successful delivery. Defines innovative solutions within the most complex and ambiguous areas of the business. Leads other managers and provides strategic direction for the organization through a comprehensive understanding of the medical device regulatory space.

Job Duties

* Manage a team of quality management in the Americas in support of operational activities across multiple business units while implementing best practices.


* Leads the development and maintenance of facility Quality Management System and associated procedures and authorizes the implementation of these, ensuring alignment to Olympus company policies.


* Responsible for product quality oversight, management and escalation from a Quality perspective, to senior leadership.


* Develop, execute and maintain facility Quality Scorecard / Dashboard, ensuring performance levels attained deliver on expected target goals and demonstrate best in class performance.


* Responsible for site audit readiness and ensures adoption and compliance to all applicable regulatory standard requirements, guidance and best practices.


* Responsible for the identification, acquisition, development and retention of high performing Quality Talent, ensuring adequate and competent Quality resources are present as needed.


* Adhere to established Quality Management System and assist with development of new/improved QMS systems across business units.


* Provide input and support for the development, implementation, and improvement of QA processes.


* Collaborate with Design Assurance, Quality Engineering, Quality System and Process Validation teams to support accuracy and continuous improvement of product designs and documentation.


* Participates in investigations, assessments, and evaluations of quality records such as deviations, CAPAs, and change controls, as necessary.


* Supports the planning process to drive continuous improvements and changes of the Quality System to ensure on-going effectiveness, efficiency and sustainability.


* Partners with senior leaders across Olympus to identify and remove blockers to ensure delivery of an integrated approach to Quality across the business.


* Engage in a positive manner with team members from all disciplines to ensure common goals are being met (production, material handling, lean manufacturing, engineering, purchasing, safety, maintenance, shipping/receiving, customer service, etc.).


* Organize, direct, and delegate tasks as necessary to lead cross-functional teams through quality response efforts.

Job Requirements



* Bachelors or Masters degree in the Sciences or Engineering.


* Minimum of 15 years Medical Device experience with B.S. degree in Science, Engineering, Pharmacy or related technical field.


* Minimum of 12 years Medical Device experience with M.S. degree in Science, Engineering, Pharmacy or related technical field.


* Minimum of 5 years management experience.


* Knowledgeable about the science and manufacturing of medical devices.


* Extensive working knowledge of international GMP regulatory frameworks, regulations and guidance.


* Track record of successful project leadership and delivery within a matrix organization.


* Will work with global teams, availability will include working across the associated time zones. International and domestic travel up to 15% of the time.




* Excellent communication skills and relationship-building.


* Problem Solving, Technical Aptitude, Attention to Detail, Solution Oriented, Effective Verbal and Written Communicator, Quality Engineering Disciplines, Quality Control Disciplines, Quality Systems Disciplines and Strategic Leadership.

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 Manager, Manufacturing Engineer, Engineer, Quality Engineer, QA, Quality, Engineering

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