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. We're currently looking for a Market Quality Engineer I to join us in our Brooklyn Park, MN office.
Let's inspire healthier lives, together.
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.
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.
* 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.
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