Market Quality Engineer I

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

The Quality Market Engineer I maintains responsibility for performing product surveillance activities for all medical devices and is responsible for assisting in the investigation of complaints and reportable events. He/ she interfaces with OEMs and local departments to promote quality improvements to both products and quality system processes by initiating and driving corrective and preventive actions. The incumbent identifies and proposes solutions to quality discrepancies and process improvements based on data collection, trend analysis and reporting activities. He/ she must be able to communicate and follow-up on event description detail with internal and external customers in order to evaluate adverse event occurrences. They provide supports in the continuous improvement effort of the MSG quality system for processing complaints in order to meet FDA, ISO and all applicable international regulatory requirements, and corporate guidelines. The incumbent performs timely closure of product complaint files in accordance with established procedures. He/ she requires general instruction for routine assignments from Manager or more experienced staff.

Job Duties

In a typical day, you will:

 

* Assist RA Analysts to conduct timely complaint and MDR investigations.

 

* As needed, the RA Engineer I will communicate with customers and field personnel, and perform on-site visits.

 

* Perform complaint file closure in a timely manner.

 

* Perform failure analysis and defect investigations.

 

* Interacts with complaint investigation teams to ensure investigation is completed in a timely manner.

 

* Provide technical solutions to address and expedite product complaints.

 

* Communicates with Internal/External customers to identify details related to complaint information and occurrence.

 

* Reviews associated complaint records to ensure the applicable assessment, investigation and analysis records are appropriate and complete.

 

* Provide technical support to technicians, complaint administration staff and production shop floor staff relative to technical investigations.

 

* Perform disposition of incoming complaints requiring an RA investigation in a timely manner.

 

* Apply systemic problem solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

 

* Work directly with the OEM to facilitate corrective and preventive action activities (CAPA) related to quality problems identified through complaint investigations and/or other sources of quality data.

 

* Participate in process validation and New Product / Repair Introduction activities as needed.

 

* As needed, provides specific complaint reports in database systems for the purpose of trend monitoring and/or complaint investigation and research assistance.

 

* Collects, summarizes and evaluates compliance performance metrics and works to identify improvement programs.

 

* Perform other related duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree in a technical discipline (e.g. EE, ME, BME, Microbiology, Chemistry, Quality Assurance), or equivalent knowledge. 

 

* Minimum 1- 2 years experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries. 

 

* General knowledge and application of technical and business concepts, procedures, and practices. Interprets company policies and procedures to resolve issues.

 

* Beginning knowledge of industry practices and standards.

 

* Specific experience in complaint-handling activities.

 

* Effective written and verbal communication skills.

 

* Strong analytical, organizational, communication and interpersonal skills are required.

 

* Computer literate with experience in Microsoft Office.

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 || 

Posted
09/26/2020
Salary Range
$75,000.00 - 119,000.00
per Year
Salary range estimated by
Location
San Jose, CA 95131-1700, US