Quality Engineer

West Pharmaceutical Services • Greenfield, IN

1d • Onsite

About The Position

In this role, you will provide technical Quality Engineering support for technology transfer, qualification, validation, manufacturing processes, investigations, risk management, and ongoing commercial production. You will apply structured problem-solving, statistical, engineering, and risk-based methods to establish and maintain effective process controls, resolve complex product and process quality issues, and improve manufacturing performance. The Quality Engineer partners with Operations, Engineering, Validation, Laboratory, Quality Systems, Supplier Quality, and other functions supporting medical device, pharmaceutical packaging and drug-device combination product programs. The role reports to the Quality Engineering Manager or Quality Operations Manager, as assigned.

Requirements

• Bachelor’s degree in Engineering, Quality, Science, Pharmacy, Statistics, or a related technical discipline, or an equivalent combination of education and relevant experience.
• 3+ years of relevant experience in Quality Engineering, process engineering, validation, manufacturing science, or regulated manufacturing within the pharmaceutical, medical device, or combination-product industry.

Nice To Haves

• Knowledge of applicable quality and regulatory requirements, including ISO 13485, 21 CFR Parts 4, 210/211 and 820 QMSR, EU GMP Volume 4, Good Documentation Practices, and relevant company procedures.
• Experience providing shop-floor Quality Assurance support and reviewing executed batch, device history, manufacturing, or equivalent production records.
• Experience with deviation and nonconformance investigations, structured root cause analysis, CAPA, change control, risk management, and data-driven process improvement.
• Experience with equipment or process qualification, process validation, PFMEA, control plans, statistical process control, process capability, technology transfer, or new product introduction.
• Experience with drug-device combination products, drug product handling, packaging or assembly, or low-volume or clinical manufacturing.
• Experience supporting customer, notified body, or regulatory audits, inspections, and inspection readiness.
• Ability to make timely, risk-based Quality decisions while maintaining appropriate independence from Operations and complying with company safety and quality policies.
• Strong written and verbal communication skills, with the ability to translate technical analysis into clear, risk-based Quality decisions.
• Thrive in a fast-paced, dynamic manufacturing environment where teamwork, collaboration, and a positive attitude drive success.
• Demonstrate flexibility, adaptability, and resilience while supporting the launch and growth of a state-of-the-art pharmaceutical and drug-device manufacturing facility.
• Embrace change, innovation, and continuous improvement as new operations, technologies, processes, and customer programs are introduced.
• Take ownership and show initiative in identifying opportunities to improve safety, quality, compliance, delivery, and operational performance.
• Work collaboratively across functions to achieve shared goals while maintaining a strong commitment to integrity, accountability, and respect for others.
• Take pride in delivering high-quality products that support customer success and improve patient lives worldwide.
• Support a culture of learning, problem-solving, operational excellence, and continuous improvement.
• Demonstrate a willingness to learn new skills, expand responsibilities, and contribute to the successful growth of the organization.

Responsibilities

• Ensure Quality Engineering activities comply with applicable regulatory requirements, corporate policies, procedures, Quality Agreements, company guiding principles, and the Code of Conduct.
• Promote Quality ownership, Right First Time execution, continuous improvement, and timely escalation of product quality or compliance risks.
• Interface with customers on technical quality matters, including product requirements, investigations, complaints, change controls, validation, risk assessments, and quality performance.
• Partner with Operations, Engineering, Validation, Manufacturing Science and Technology, Customer Quality, Supplier Quality, and other functions to resolve technical quality issues and maintain effective process controls.
• Provide Quality Engineering oversight for technology transfer, new product introduction, scale-up, manufacturing readiness, process performance qualification, and transition to routine commercial manufacture.
• Review and approve qualification and validation protocols and reports for equipment, processes, packaging, and computerized systems, as applicable.
• Translate customer and product requirements, Critical to Quality characteristics, and Quality Agreement responsibilities into effective manufacturing, inspection, and acceptance controls.
• Develop, review, and maintain quality specifications, inspection strategies, sampling plans, defect libraries, control plans, and manufacturing control strategies.
• Provide technical Quality input to product and process risk management, including PFMEA, risk assessments, control plans, and lifecycle maintenance of risk controls.
• Review and approve change controls affecting processes, equipment, facilities, materials, inspection methods, packaging configurations, software, or product quality.
• Lead investigations for assigned areas of process ownership and provide QA oversight and support for investigations led by other functions, ensuring appropriate root cause analysis, containment, corrective actions, and preventive actions.
• Develop and assess corrective and preventive actions addressing product, process, systemic, or recurring quality issues.
• Analyze manufacturing and quality data using appropriate statistical methods to identify adverse trends, assess process capability, and drive sustainable improvement.
• Document clear, timely, and risk-based Quality decisions, conclusions, and recommendations while maintaining appropriate Quality independence.
• Support customer, internal, notified body, and regulatory audits or inspections as a Quality Engineering subject matter expert, and coach cross-functional teams in structured problem-solving, statistical methods, validation, and risk-based decision-making.

Benefits

• Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.
• Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level