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Director, Market Quality

Req ID:  1843

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

This position is responsible for establishing and maintaining compliance with Food & Drug Administration (FDA) laws and regulations throughout OSTA for the management of complaint processing,.  The incumbent in this position will ensure the effective and timely resolution of all complaint investigations.   This position is responsible for is responsible for leading and directing the complaint handling process projects and quality and data monitoring program within Market Quality. The Director  has responsibility the management  administration of the quality and data monitoring program and organizing complaint handling activities through project management.  

Job Duties

* Establish, implement, monitor and maintain the complaint processing and investigation systems to ensure the effective and timely resolution of all complaint investigations in compliance with all regulatory agencies.  
 

* Works with management and staff, including Olympus staff outside of the U.S. to coordinate schedules and resources necessary for timely completion of projects.  

 

* Demonstrates the ability to form and motivate cross functional groups to accomplish related project objectives.
 

* Work with other key complaint intake departments, such as service and repair, to ensure that complaint intake systems, processes and staff are aligned with complaint process requirements.
 

* Provides guidance to all departments on KPI achievement, facilitating discussions to enable measurement, management, and reporting.  Works with department leaders to identify meaningful metrics to improve processes and care.  

 

*  Develops systems to collect, measure, and report performance improvement results.

 

*  Participates in system-wide data analytics initiatives.
 

* Works with OCI, LAD and OUS departments to ensure that all organizations are executing complaint processing consistent with company goals, objectives and KPIs.  

 

* Where action is required to achieve objectives, identifies the solutions within a cross functional team and drives projects through to completion.
 

* Maintain knowledge and awareness on staffing and resources for all aspects of complaint processing activities, advising and escalating when necessary to ensure complaint transactions and timeliness are not compromised.
 

* Manage, mentor and supervise all staff assigned in the complaint processing unit to ensure that the effective performance of complaint processing responsibilities.  Educate and lead staff and associates on regulatory policies and practices.
 

* Manage trend analysis and reporting activities including monthly quality reporting of emerging quality / regulatory issues. 
 

* Perform all other related duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree required.

 

* Minimum of 5 years management level experience in a drug/device manufacturer/ distributor [environment], with strong concentration in QSR compliance and quality assurance.

 

* Travel as required, including international travel.

 

PREFERRED QUALIFICATIONS:

 

* Demonstrated experience in developing and leading a top performing RA team is required.

 

* Proficient understanding of medical device regulations which include complaint handling and medical device reporting. 

 

* Professional certification in Regulatory Affairs Professional Society is desirable, but not required.

 

* Experience with communicating with domestic and international regulatory bodies.  

 

* Strong analytical, organizational and communication skills required.

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) || California (US-CA) || San Jose || 

 

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