Quality Project Engineer

Bayer•Saxonburg, PA

8d•$128,000 - $145,000

About The Position

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. 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]. Include reference code below with resume. YOUR APPLICATION Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders. Bayer is an E-Verify Employer.

Requirements

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
implementing risk management processes to assess, control & monitor quality risks during the product lifecycle
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

Responsibilities

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