Quality Project Engineer

Quality Project Engineer for Saxonburg, PA to support quality engineering initiatives within manufacturing operations; develop & maintain quality engineering methods to meet customer, internal and regulatory requirements; evaluate existing quality system & manufacturing processes and implement projects to improve productivity and efficiency; provide QA project support for site New Product Development engineering introductions; create quality plans; conduct FMEA. Requires Master's in Industrial or Quality Engineering or closely related field and 3 yrs experience developing, supporting & maintaining quality engineering methodologies for large-scale manufacturing to meet customer and regulatory requirements; addressing quality issues & production output with internal stakeholders in a GxP environment; leading and/or supporting manufacturing validation activities, including IQ, OQ, PQ and test method validation, in accordance with ISO standards; using Six Sigma, A3, & 7 QC tools and/or methods to facilitate investigations of failures identified by customer complaints, internal non-conformances, and manufacturing yield issues in batch production; leading and/or supporting Corrective and Preventative Actions, including identifying & eliminating root causes using A3, PDCA and/or 8D methodologies and ensuring closure of action items in a 24-7 manufacturing environment; collaborating with cross-functional teams to drive continuous improvement initiatives & ensure alignment with quality objectives; creating data models & reports in Visual Basic, Excel Power Query, and/or PowerBI to analyze continuous manufacturing datasets, automate monitoring and reporting on quality metrics, and enable identification of trends and areas for improvement; identifying & mitigating quality risks during product development & manufacturing in accordance with ISO 9001 and/or ISO 13485 standards; and implementing risk management processes to assess, control & monitor quality risks during the product lifecycle. Will also accept a Bachelor's degree in said fields & 5 yrs progressive, post-Bachelor's stated experience. Up to 10% U.S. and/or int'l travel req'd. Salary Range: Employees can expect to be paid a salary between $128,000.00 to $145,000.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. The offered salary may vary within this range based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors. Mail resume to Jill Martin, Bayer HealthCare LLC, 800 N. Lindbergh Blvd., E2NE, St. Louis, MO 63167 or email resume to [email protected]. Reference Job Code 864593.