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Job Title Advanced Quality Engineer (Medical Device)
Date Posted 9/24/2013
Max Salary $90,000.00
Job Type Full-Time Regular
Min Experience 7 Years
Position Id EB-1085155467
Job Description
Job Description

Assumes primary responsibility in leading global, cross-functional Advanced Product Quality Planning (APQP) teams for successful new product launches. Must be able to interface effectively across multiple functions and at various levels of the organization.
Responsible for collaborating with design engineers and other functional stakeholders during the Design and Development phase of New Product Introduction (NPI) to ensure the following have been addressed prior to a frozen design:
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 (DFMEA) events as a means of mitigating potential causes of product failures.
Responsible for collaborating, as appropriate, with design engineers (NPI), supplier development engineers, plant quality engineers and quality data analysts and other functional stakeholders during the Pre-Production phase of New Product Introduction (NPI) to ensure the following have been addressed prior to launch:
If applicable, Process Failure Mode and Effects Analysis (PFMEA) events as a means of mitigating potential causes of process failures.
Development of control and test plans.
Measurement System Analysis (MSA), including the evaluation of gage repeatability and reproducibility (Gage R&R).
Capability studies on key characteristics.
Process audits, as needed, at Invacare manufacturing locations or at off-site supplier locations.
Production Part Approval Process (PPAP) - Coordinates part approval submissions in conjunction with Buyers, helping to communicate expectations of the PPAP to suppliers.
Responsible for collaborating with quality data analysts and design engineers (sustaining) in the monitoring of product quality performance (through feedback loops such as: returns data, repairs, complaints, etc.) for assigned product category. Lead efforts in driving continuous performance improvement for all products within assigned product category.
Participates in Engineering Change Notice (ECN) activities and represents the quality function, as appropriate.
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

Required Skills

Education: Bachelor of Science degree (Mechanical, Electrical, Industrial Engineering, etc.) or equivalent engineering degree.
Experience: 7+ years in manufacturing and/or quality, with 3-5 years minimum participating on and/or leading Advanced Product Quality Planning (APQP) teams.
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

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