Staff Quality Engineer - O'Hara, PA

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Staff Quality Engineer - O'Hara, PA

Staff Quality Engineer – O’Hara, PA

JOB DESCRIPTION SUMMARY

Provides leadership to the Quality Control team, overseeing laboratory activities related to the sampling, testing, and documentation of raw materials, in-process materials, finished products, and stability samples. Responsible for reviewing and evaluating critical documentation for accuracy and compliance, directing the development of new analytical testing methodologies, and implementing strategies to enhance laboratory efficiency, capacity utilization, quality, safety, and regulatory compliance.

PURPOSE

Provides enterprise-level technical quality leadership and strategic quality engineering support for products and manufacturing processes within a regulated medical device environment. Serving as a recognized subject matter expert, this position leads highly complex, cross-functional initiatives spanning manufacturing support, new product and process introductions, sustaining engineering, compliance, risk management, validation, and continuous improvement. The role identifies future capability needs and emerging clinical and market trends, supports the development and implementation of quality strategies, helps resolve execution challenges, and collaborates with internal and external partners to strengthen technical capabilities. By applying advanced statistical, problem-solving, validation, and risk-management methodologies, the Staff Quality Engineer improves product quality, manufacturing performance, and Quality Management System effectiveness; influences technical and business direction; ensures scalable quality capabilities are consistently applied across the organization; and communicates complex technical concepts effectively to Manufacturing, Engineering, Operations, Regulatory Affairs, Supply Chain, and internal and external partners.

YOUR TASKS AND RESPONSIBILITIES

• Provide quality leadership for day-to-day manufacturing operations across multiple products and production processes;

• Ensure products and manufacturing processes comply with customer requirements, regulatory standards, and the Quality Management System;

• Lead complex investigations involving customer complaints, nonconformances, process failures, manufacturing yields, and unfavorable quality trends;

• Apply structured problem-solving and root-cause analysis methodologies to identify failure mechanisms and develop sustainable corrective actions;

• Develop risk-based validation strategies, protocols, acceptance criteria, and reports in collaboration with Engineering and Manufacturing;

• Apply statistical methods and Design of Experiments to evaluate process performance, establish capability, and support data-driven decisions;

• Apply advanced quality engineering and risk-management tools, including FMEA, statistical analysis, Six Sigma, and structured problem-solving methodologies;

• Lead quality-impact assessments for changes involving products, processes, equipment, materials, suppliers, and controlled documentation;

• Ensure risks are appropriately identified, evaluated, controlled, documented, communicated, and monitored throughout the product and process lifecycle;

• Provide quality engineering leadership for new product introductions, design transfers, product transfers, equipment installations, and new or modified manufacturing processes;

• Lead complex, cross-functional quality, compliance, cost, productivity, and process-improvement projects;

• Use statistical methods and Six Sigma tools to reduce variation, eliminate defects, improve process capability, and increase manufacturing efficiency;

• Analyze quality and manufacturing data to identify emerging trends, recurring issues, and opportunities for proactive improvement;

• Serve as a quality engineering subject matter expert and provide technical guidance and mentoring to engineers, technicians, and cross-functional team members;

• Lead technical discussions and clearly communicate complex quality, compliance, statistical, and engineering matters to internal and external stakeholders.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• Bachelor’s Degree in Engineering or a closely related technical discipline.

PREFERRED QUALIFICATIONS

• 15 years working experience exercising technical, process, and organizational skills to maximize functional quality capability and performance.

Employees can expect to be paid a salary between $130,800.00 to $196,200.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..

This salary range is merely an estimate and may vary 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.

This posting will be available for application until at least 11-2-26.

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.

Location: United States : Pennsylvania : Pittsburgh Heilman

Division: Pharmaceuticals

Reference Code: 891290

Contact Us

Email: [email protected]