Product Quality Engineer
3200 Lakeside Drive Santa Clara, CA 95054
Voca has an immediate opening available for a Product Quality Engineer in Santa Clara, California!
- Analyzes customer complaints, events and other post marketing surveillance data by examining returned devices and data for patterns and trends and investigating when necessary.; Investigates customer complaints related to product quality or patient safety.; Investigates identified trends by starting a formal trend investigation and trend report and working on cross-functional teams.; Communicates product performance by formal presentations to management committees and design teams, supporting published product performance reports and supporting customer requests for performance information either directly or through the sales organization.; Provides input for process improvement and helps develops tactical approaches to implement team strategies.; Develop test plans, procedures, justifications papers and provide engineering support for new product complaint readiness.
- This position is NonExempt. Hours over 40 will be paid at Time and a Half. Primary contact for engineering support of In-Process Inspectors. Support production efforts and process improvements (trend analysis, process validation, SPC). Coordinate In-Process MRB activities. Support Quality Systems (perform audits, SOP improvement, training, CAPA investigations). Ensure from the Quality prospective the transfer of new products from R&D to Production. Support Statistical Techniques and SPC interpretation. Present PPR and Management Review.
0-1 years of industry experience in ISO-9001 environment, preferably medical device. Bachelor of Science or higher degree in ME, IE or equivalent.
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