21 days old

Product Quality Engineer

Kelly Services
San Jose, CA 95115
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as a **Product Quality Engineer** at a prestigious Fortune 500 company working in **San Jose, CA** .

This is a temp-to-perm position at 40 hours per week.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the submit now button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position ( ) however your resume must be received via the submit now button included within.

**Job Description:**

The Market Quality Engineer will be responsible for performing product surveillance activities for all medical devices and is responsible for assisting in the investigation of complaints and reportable events. 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. Identifies and proposes solutions to quality discrepancies and process improvements based on data collection, trend analysis and reporting activities. Must be able to communicate and follow-up on event description details with internal and external customers in order to evaluate adverse event occurrences. Provides supports in the continuous improvement effort of the OSTA quality system for processing complaints in order to meet FDA, ISO and all applicable international regulatory requirements, and corporate guidelines. Performs timely closure of product complaint files in accordance with established procedures. Requires general instruction for routine assignments from Manager or more experienced staff.

**Primary Duties and Responsibilities:**

+ Assist Market Quality Analysts to conduct timely complaint and MDR investigations. As needed, the Market Quality Engineer 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 associate 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 a Market Quality 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.


+ A four-year degree in a technical discipline (e.g. EE, ME, BME, Microbiology, Chemistry, Quality Assurance), or equivalent knowledge.

+ 1-2 years experience dealing with regulatory, manufacturing or quality assurance issues environment.

+ Effective written and verbal communication skills.

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

+ Computer literate with experience in Microsoft Office.

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.



Posted: 2020-10-05 Expires: 2020-11-05

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Product Quality Engineer

Kelly Services
San Jose, CA 95115

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