|Job Title||Advanced Quality Engineer (Medical Device)|
|Job Type||Full-Time Regular|
|Min Experience||7 Years|
Assumes primary responsibility in leading global, cross-functional Advanced Product Quality Planning
Responsible for collaborating with design engineers and other functional stakeholders during the Design and Development phase of New Product Introduction
Proper identification of all safety and performance critical components.
Identification of all key characteristics along with applicable tolerances.
If applicable, Design Failure Mode and Effects Analysis
Responsible for collaborating, as appropriate, with design engineers
If applicable, Process Failure Mode and Effects Analysis
Development of control and test plans.
Measurement System Analysis
Capability studies on key characteristics.
Process audits, as needed, at Invacare manufacturing locations or at off-site supplier locations.
Production Part Approval Process
Responsible for collaborating with quality data analysts and design engineers
Participates in Engineering Change Notice
Conducts courses on quality system tools & techniques such as 8-D problem solving, FMEA, PPAP, APQP, Six Sigma, Lean, etc. with targeted Invacare associates.
Serves as an expert technical resource to quality councils as required.
Maintains “best-practices” repository and champions the use of best practices as a key input into product design through the following activities: I/O Matrix, testing, risk assessment, Design FMEA, etc.
Complete all required training applicable to assigned position
Additional duties as requested or required
Education: Bachelor of Science degree
Experience: 7+ years in manufacturing and/or quality, with 3-5 years minimum participating on and/or leading Advanced Product Quality Planning
Preferred Training: APQP, FMEA, PPAP, statistical techniques, Gage R&R, quality auditing, problem solving, Six Sigma, Lean.
Project management and negotiation skills.
Recommended Credentials: CQT, CQE.
Influencing skills, ability to lead cross-functional teams globally.
Travel approximately 25%.
|Location (Shows on Web)||Northeast Ohio|