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 of equipment, formulas and processes on an ongoing basis.
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
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