Quality Engineer - Direct Hire role
Manpower

Job Info

Job Description

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 612-202-6163.