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Sr/Principal Quality Assurance Engineer

Company: Monteris Medical
Location: Minnetonka
Posted on: June 19, 2022

Job Description:

Purpose and ScopeThis role works under the direct supervision of the Principal Quality Engineer or above (see Org Chart) to support product realization from material acquisition to product build/test/release to delivery/service to returns. -Activities include CAPA execution, complaint investigation, inspection and test method development, implementation of manufacturing process controls including process validation, supplier quality, and risk management. -This role will execute, and finalize special projects to continuously improve product and process quality as well as quality system improvements. Primary Organization Responsibilities --- - - - - - - -Lead cross-functional improvement efforts in support of the product and Quality System --- - - - - - - -Lead CAPA (root cause analysis, corrective and preventive action planning, solution development, execution, and verification). --- - - - - - - -Resolves first level manufacturing and technical issues in a timely manner via NCR process. --- - - - - - - -Performs product inspection, testing, and final release authorization. --- - - - - - - -Review completed production orders and shipments for completion/accuracy. --- - - - - - - -Review field service records and maintain capital equipment DHR. --- - - - - - - -Assists with returns decontamination, complaint investigation/analysis and final release of sterile products including collaboration with contract manufacturers as applicable. --- - - - - - - -Assists with equipment and facilities qualification, calibration and maintenance. --- - - - - - - -Assists with Product Surveillance and Risk Management activities including FMEA development. --- - - - - - - -Performs process validation planning and execution, revalidation assessments. --- - - - - - - -Implements and trends manufacturing and quality system indicators (e.g. SPC, scrap trending, etc.). --- - - - - - - -Performs internal audits as requested. --- - - - - - - -Performs other duties as apparent or assigned. --- - - - - - - -Support line transfers, --- - - - - - - -Controlled Environment Validation, Maintenance, and Monitoring --- - - - - - - -Ability to support external and internal audits. --- - - - - - - -May manage inspectors/technicians. --- - - - - - - -Provide mentorship/guidance to junior engineers.Personal Qualifications and ExperienceEducation/Experience --- - - - - - - -Bachelor's degree required, biomedical, electrical or mechanical background desired. -Advanced technical or management degree a plus. --- - - - - - - -Minimum of 6 - 10 years of medical device manufacturing with specific experience in Class 2/3 devices. --- - - - - - - -ISO 13485:2016 Lead Auditor Certification strongly desired.Skills/Abilities --- - - - - - - -Excellent documentation and technical writing skills. --- - - - - - - -Proficient with software packages in presentations, data processing, engineering reports and Microsoft project. --- - - - - - - -Experience in root cause analysis, electrical and mechanical problem solving. --- - - - - - - -Experienced in complaint handling, post market surveillance, risk assessment, test method development, and process validation. --- - - - - - - -Comfortable in a fast paced, evolving and entrepreneurial organization. --- - - - - - - -Willing to spend "hands-on" time on the production floor to understand products and processes. --- - - - - - - -Lean principles and Statistical Process Control experience desired. -Monteris Medical reserves the right to hire at the Sr. or Principal Engineer level based on qualifications.

Keywords: Monteris Medical, Minnetonka , Sr/Principal Quality Assurance Engineer, Engineering , Minnetonka, Minnesota

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