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Sr. Quality Engineer

Marlborough, Massachusetts | Direct Hire

Job ID: 47706 Industry: Engineering

Responsibilities

•  Collaborating with Engineering and Marketing to define consumer needs, cascade them down into product design as Critical to Quality (CTQ) requirements through product specifications and into manufacturing processes

• Develop qualification test plans and review verification and validation reports to assure product robustness and ensure best in class processes, design guidelines and practices are used in products

• Analyzing all available sources of actionable data to develop an ‘ expert’ understanding of both functionality and usability of products to identify improvement opportunities

• Leading Risk Assessments (Design and Manufacturing) and risk mitigation plans during the product development cycle

• Acting as a ‘ bridge’ to transfer product design to production. Actively engage in implementing lessons learned, best practices during development phases, perform manufacturing readiness reviews and follow through on any open risk items to closure 

• Leading periodic quality review meetings and following up on identified improvement initiatives to drive Root Cause Analysis (RCA), implementing robust corrective actions and reducing Cost of Quality (CoQ)

• Responding to customer field issues with CAPA that is effective in preventing recurrence

• Identifying, analyzing and interpreting quality trends, risks, and opportunities and making appropriate recommendations to drive improvements

• Collaborating with global counterparts, cross functional teams and manufacturing representatives to drive quality improvement initiatives needed to assure smooth launches of new products and low returns from the field

Qualifications

•  Bachelor of Science Degree in Electro-Mechanical, Mechanical engineering or equivalent degree

•  5-10 years of related quality Engineering experience and statistical / data analysis skills 

•  ASQ certifications – CQE, CRE, Six Sigma Green Belt/Black Belt certification a plus

•  Well versed in ISO9001, ISO13485, SPC, CPK, GRR, FMEA

•  Results Orientation with appropriate focus on short and long-term goals. Motivated by achievement, and persists until  goals  are  reached, conveying a sense of urgency  

•  Problem Solving & Decision Making – identifies and solves problems, develops innovative solutions, takes ownership and acts decisively, shows good judgment

•  Excellent interpersonal communications skills; strong written, verbal and presentation skills

•  Knowledge of electro /mechanical parts, components and assemblies such as metal, plastics, etc.

•  Flexible to travel up to 10% both domestic and internationally

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