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Market Quality Engineering Supervisor

Req ID:  4238

Working Location: MINNESOTA, BROOKLYN PARK; CALIFORNIA, SAN JOSE; TENNESSEE, BARTLETT 

 

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 provides leadership to the Market Quality Engineers performing complaint processing and investigation. Directs activities associated with complaint investigations to ensure timely closure of investigations. Works closely with Market Quality Engineers and OEMs to promote quality improvements to both products and quality system processes by initiating and driving corrective and preventive actions. 

Job Duties

* Works with management and staff to ensure the successful execution of established procedures and policy for complaint processing.   Ensures the completion of all complaint investigations in a uniform and timely manner.

 

* Assists Market Quality Management in planning complaint investigation activities, identifying roadblocks and strategizing on various pathways for investigating complaints with in-house staff, vendors and Olympus facilities outside the U.S. Identifies problems, develops and executes solutions to address challenges in processing complaints in a uniform and timely manner.

 

* Monitors the complaint processing system and FDA expectations for compliance. Prepares and develops recommendations and strategies on improvements in the complaint processing system.

 

* Supports Market Quality Management in interacting with field employees on potential quality issues, acting as the initial screen and feedback mechanism for field reports.

 

* Coordinates and oversees regular meetings between OEMs and Market Quality staff to facilitate quality improvements related to product complaints and MDR’s. 

 

* Supports Market Quality Management and staff in the evaluation, investigation, and documentation of all alleged Product Quality Issues (PQIs) and Medical Device Reports (MDR's).

 

* Coordinates production of routine and ad hoc trend reports.

 

* Ensures the completeness and adequacy of documentation developed in support of complaint investigations.

 

* Acts as a liaison between Market Quality, ITS and outside developers to monitor, maintain, improve and validate the functionality of the EtQ complaint system.

 

* Provide instruction and feedback to the group as needed and ensure completeness and consistency of complaint and Regulatory reporting documentation. 

 

* Perform classification of complaints and escalate complaints that require additional review. Perform Failure Analysis investigation review and escalate complaints that require additional review.

 

* Perform other related duties as directed

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor of Science in Engineering.

 

* Minimum of 2 years of experience in medical device field, with experience in the following areas:

 

Supervisory or Lead experience (or equivalent) role.

Strong working knowledge of Medical Device Complaint files and quality record documentation

Strong working knowledge of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD/MDR requirements, etc.)

 

* Must demonstrate strong analytical ability required to perform thorough analysis needed to resolve or escalate complaints.

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 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) || Minnesota (US-MN) || Brooklyn Park || 


Nearest Major Market: Minneapolis

Job Segment: Quality Engineer, Manager, Engineer, Quality Manager, Engineering, Management, Quality

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