Share this Job
Apply now »

Executive Director, Global CAPA Process

Req ID:  3305

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  Executive Director, Global CAPA Management is responsible for developing and implementation of business strategies to effectively manage all “Core QMS Issue Management” processes (ref: GPO #2), see below, including CAPAs, NCs, deviations, calibration, etc. on a global basis. The Executive Director will manage the Olympus CAPA Process and sub processes e.g., NCs, deviations, calibration in all Olympus Global Locations and have Management Responsibility for governing the CAPA process utilized globally and act as the top most CAPA review board.  In addition, the Executive Director of Global CAPA management will manage a small organization at the global level to manage Global CAPAs. This role will extensively include strategic planning and direction with regional, local operational support & oversight as needed.

Global Process Owner (GPO) #2 global QMS process responsibilities:

CAPA-4, Noncoformities, Collaboration-1, Sterility OOS, Investigation, Deviation Handling 

Job Duties

* Ensure the proper execution of the Global CAPA process and sub processes within GPO #2.

 

* Ensure the proper management of the Global CAPA organization and GPO #2.

 

* Lead the development of the Future State of the Global CAPA process and organization.

 

* Manage the GPO #2 and Global CAPA functions Budget and Headcount.

 

* Manage the relationship with IT as it relates to the collection and processing of CAPA and sub processes.

 

* Act as global SME as it relates to all things “CAPA”.

 

* Lead the organization that will represent the Olympus in Regulatory (global) Body inspections as they relate to CAPA management.

 

* Act as the most responsible global  executive when it comes to communicating with Regulatory Authorities as those communications relate to CAPA management.

 

* Provide data to those internal organizations that require it to meet those organizations.

 

* Quality Management System requirements for Management Reviews or other ad hoc requests.

Job Requirements

REQUIRED QUALIFICATIONS

* Bachelor’s Degree in Business, Engineering, Life Sciences, or related technical degree.

 

* Minimum of 8 years leading a global organization in medical devices at the director level or higher.

 

* Other Considerations (travel/hours availability, etc.):Ability to travel up to 33% of time domestically and internationally.

 

PREFERRED QUALIFICATIONS

* Strong Interpersonal skills. 

 

* Ability to manage complexity, analytical, people management on a global basis, Office 365.

 

* Works well with different cultures.

 

* Works well dealing with regulatory agencies.

 

* Strong Executive Presence.

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 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 www.olympus-global.com.

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: CAPA, Manager, Engineer, Quality Manager, QA, Management, Engineering, Quality

Apply now »