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Market Quality Manager

Req ID:  1846

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, Market Quality Manages, manages the Global MDR Submissions Analysts who are responsible for preparing and submitting Medical Device Reports to the FDA and assisting with submissions to other regulatory agencies worldwide in conformance with applicable local, regional and international regulations.  This position manages and directs these activities ensuring the timely review and processing of potential adverse events.  The Market Quality Manager works closely with technical staff in Global MDR Submissions and other departments at the San Jose and Bartlett repair facilities and at the manufacturing sites. The Market Quality Manager communicates with the FDA or other interested internal and external parties as needed. 

Job Duties

* Manage the daily operations of Global MDR Submissions Analysts who are responsible for preparing and submitting Medical Device Reports to the FDA. Manage the daily operations of Global MDR Submissions Analysts who are responsible for overseeing and approving adverse event and vigilance reports associated with OSTA products sold or distributed internationally. Monitor complaint activities associated with OSTA products worldwide to ensure timely submissions in all markets.  Work with local OSTA distributors as needed to resolve adverse event issues and assist with investigations. Establish Key Performance Indicators (KPIs) for the Global MDR Submissions Submission team to monitor internal processes and performance metrics necessary to ensure timely and uniform submissions.

 

* Work with QARA Management from throughout Olympus to improve and streamline processes  and systems (e.g. EtQ, SAP, Datasweep, etc.) needed to support both local and global targets and objectives.

 

* Work with the Post-Market Surveillance department to establish tools and methods needed to monitor external sources of information such as media reports and clinical studies that may require complaint investigation or follow-up.

 

* Maintain all records associated with complaint and MDR submissions files necessary to maintain regulatory compliance, including lists and reports.

 

* Prepare other types of regulatory submissions to FDA and other interested external parties such s requests for additional information.

 

* Support audits of the complaint system conducted by FDA, MDSAP and all other external and internal parties. 

 

* Perform other duties as required.

Job Requirements

REQUIRED QUALIFICATIONS:

 

Must have a minimum of 10 years combined experience in medical device complaint handling, medical device adverse event reporting and/or clinical experience.

 

PREFERRED QUALIFICATIONS:

 

* Work experience must include a strong concentration in QSR compliance and complaint processing activities.

 

* Clinical background strongly preferred.

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 || 

 

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