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Quality Engineer

Overview
Quality Engineer
Summary
The Quality Engineer ensures the executional excellence of product launches by providing timely (as early as Stage 1, i.e., concept stage) manufacturing process-specific input; acting as the receiving point of Technology Transfer and ensuring proper Qualification/Validation of equipment, formulas and processes on an ongoing basis.
Responsibilities
Role Accountabilities and Responsibilities ? Become an expert in the fundamentals of the relevant manufacturing equipment & processes ? Perform Statistical Process Control (SPC) tests in order to develop a line capability database (manufacturing and packaging) ? Provide Plant-relevant input into FMEA's, lessons learned, and DfM ? Liaison with R&D Process, Product, & Package Development & Analytical to design appropriate tests and scale-up trials ? Provide recommendations for opportunities for cost savings and efficiency gains ? Responsible for the 'Receiving End' of the Technology Transfer Process as well as input to the process during development ? Responsible for process qualifications of minor changes to formulations (G2G projects, raw material qualifications, etc) ? Project Management Skills ? Assist/facilitate root cause analysis and problem-solving
Qualifications
Education and Experience ? BS/MS degree in related field (Quality Engineering certification desirable) ? Minimum of 5 years experience in the consumer products, medical device, and/or pharmaceutical industries ? Experience working in a plant environment with manufacturing, contractors and suppliers. Skills and Competencies ? Knowledge of QE, auditing of manufacturing operations for medical devices, OTC and /or pharmaceutical industries. ? Lean Six Sigma Black Belt a plus ? Experience effectively partnering with outside contractors. ? High initiative with demonstrated results achievement and orientation. ? Excellent influence, persuasion, verbal and written communication skills required. ? Trained auditor in GMP, and ISO 9001 or 13485
Equal Opportunity Employer/Veterans/Individuals with Disabilities



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