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Product Quality Program Leader

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Full-Time
  • Westborough, Massachusetts
  • Post Date: July 8, 2019
  • Apply Before: August 31, 2019
Job Level : Experienced
Industry : Healthcare, Life Sciences
Qualifications : Bachelors Degree
Job Description

Lead collection, analysis, and application of Product Quality Data for the entire plant. Drive awareness on issues and opportunities for defect reduction and avoidance using Quality Data. Program Leadership on Product Quality with focus on timely actions, communications, and Cost of Quality.

Essential Responsibilities:

• Develop and maintain a wing to wing product quality framework that contains DPUs, Yield Rates, Cause Factors, and Customer Complaints for Hardware, Cleanroom, and Hollow Fiber
• Generate and maintain chronological data to communicate defect trends and pareto analysis. 
• Identify and communicate the Recommend Actions to drive reduction in cost of quality through supplier engagement, design controls, and workforce training 
• Represent the plant in Product Quality Reviews at Business Unit Level. 
• Create a Vendor Recovery Framework to drive reduction in Cost of Quality
• Create and maintain an Ops Rhythm on communication with QA, SQE, SOU Teams. 
• Meet the metric on timely disposition and closure of non-conformance records. 
• Lead CAPAs and Investigations on major non-conformances and audit findings
• Generate Concessions and Deviations while adhering to QMS requirements and ensure timely closure. 
• Develop a framework for Cost of Quality that accounts for the loss of time and delays on shipments. 
• Provide yield and DPU targets for NPIs

Qualifications/Requirements:

• B.S. Degree in Mechanical, Electrical, Industrial Engineering or related technical degree and 5
years’ experience years of experience in production, engineering 
• Previous experience with ISO standards specifically when it comes to material non-conformance and internal/ external audits. 
• Proven capabilities to communicate, and influence in a cross-functional environment. 
• Previous experience in High volume manufacturing environment. 
• Excellent problem-solving abilities using analytical and logical thinking skills
• Understanding of QA-QC and testing procedures
• Good analytical and planning skills

Desired Characteristics:

• Demonstrate the capability to excel in a Cross-Functional Team Environment. 
• Demonstrated ability to identify & implement best practices.
• Demonstrated ability to perform with high levels of ambiguity and complexity.
• Previous Project Leadership Experience

About Us
We are GE Life Sciences

There is no other life sciences company quite like GE Healthcare Life Sciences.   A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine.  For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy.  GE Healthcare Life Sciences works with cutting-edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world.GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

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