Quality Engineer - Direct Hire role

**QUALITY ENGINEER - PLYMOUTH, MN. - SALARY NEGOTIABLE**

**RESPONSIBILITIES:**

* Responsible for all aspects of Product Reliability manufactured internally and externally

* Develop qualification strategy in collaboration with R&D and Engineering for both internal and external

* Facilitate qualification risk assessment

* Execute and manages product qualifications

* Publish Qualification schedules and reports

* Assures that qualification will ensure compliance to current company, customers and industry standard reliability goals and requirements including CFR 820 (FDA) and ISO 13485

* Work with R&D and Engineering teams to define and report KPI's (joint effort with Engineering teams)

* Work with R&D and Engineering teams to support the smooth transition of product into Manufacturing. Review V&V and also equivalency test

* Lead root cause Analysis and corrective actions to address Qualification failures

* Post market surveillance - Lead root cause analysis and derive CAPA (corrective and preventive actions) in conjunction with CQE /SQE and customer service (post market surveillance)

* Evaluate Engineering change orders and supplier process change request and evaluate risk / impact to product Quality and Reliability. These proposed changes should be presented during Change Control Board meeting

* Interface with Engineering, Operations and Product Management to design and implement appropriate verification methodology and documentation supporting release of products (alpha, beta, final)

* Define quality inspection criteria to ensure projects, products and processes comply with the relevant requirements of the QMS

* Analyze failure, corrective and preventive action to respond to internal/external customer complaints

* Create and maintain company quality documentation, such as manuals, procedures, etc.

* Continuously improve QA processes and procedures.

* Oversee quality process at third part manufactures with the help of Supplier Quality team

* Support preparation of Quality related documentation for submission to FDA for medical device approval and/or response to FDA inquiries.

**QUALIFICATIONS:**

* Minimum BS/BA in scientific or engineering field

* 5+ years of experience in FDA-compliant medical device industry preferably IVD

* Thorough knowledge reliability requirements for Medical devices

* Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards

* Familiar with EN 60601, Safety requirements for medical electrical systems

* Familiar with ISO 62304, Medical Device Software - Software Life Cycle processes

* 5+ years of experience in verification/validation of diagnostic medical products - point of care experience is a plus.

* 4 or more years of experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485 and ISO 14971 standards

* Lead role (administrative or technical) in one or more FDA audits for review of a medical device

* Experience with Microsoft-based tools

**_If interested, please contact Jenna at ._**

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.