Share this Job
Apply now »

Product Investigation Supervisor

Req ID:  304

Working Location: CALIFORNIA, SAN JOSE 

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 Product Investigation Supervisor provides leadership to the RA Technicians who perform the product investigation process. He/ she directs activities associated with product failure analysis and evaluation of returned product complaints.  Works closely with Technicians to determine root cause and investigation requirements. He/ she collaborates with OEMs on emerging issues.  The Supervisor will ensure that the department activities are performed in conformance with US Food and Drug Administration Quality System Requirements (QSR) and company policies and procedures.  The Supervisor will also audit the investigation processes to ensure regulatory compliance.

Job Duties

In a typical day, you will:

 

* Plan product investigation activities of technicians by identifying roadblocks and strategizing on various pathways to ensure technicians successfully execute their duties inc ompliance with regulatory requirements.

 

*  Works with management and staff to ensure the successful execution of established procedures and policy for complaint investigations.   

 

* Ensures the completion of all investigations in a uniform and timely manner. 

 

* Supports management and staff in planning complaint investigation activities, identifying roadblocks and strategizing on various pathways for investigating complaints with in-house staff, OEMs and Olympus manufacturers.   

 

* Identifies problems, develops and executes solutions to address challenges in processing complaint investigations in a uniform and timely manner.

 

* Prepares and develops recommendations and strategies on streamlining the integration of new product investigations. Works in collaboration with OEMs to implement new investigation documentation and provides training on new product.

 

* Maintain all records associated with complaint files and Medical Device Reports as required for regulatory compliance.

 

* Supports management and staff in the evaluation, investigation, and documentation of all adverse event investigations, as needed.

 

* Coordinates production of routine and ad hoc trend reports on complaint investigation productivity and staff performance.

 

* Accomplishes results by managing staff and team performance and by creating a positive learning environment.  Provide clear, specific and respectful coaching and feedback to staff regarding job expectations and job results.

 

* Perform other related duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor of Science, Engineering, or Scientific discipline, or equivalent knowledge.

 

* Minimum of 3 years of complaint handling experience within medical device manufacturing environment, with strong concentration in regulatory compliance and/or quality assurance.
 

* Strong analytical, organizational and communication skills required.
 

* Demonstrated knowledge of FDA Quality System Regulations 21CFR803/820 and ISO 13488/13485. 

 

PREFERRED QUALIFICATIONS:

 

* Previous supervisor/ team lead experience preferred.

 

* Experience with quality system development, implementation and/or revision 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.

 

Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.  EOE Minorities/Females/Veterans/Disabled

 

Posting Notes: || United States (US) || California (US-CA) || San Jose || 

Apply now »