Quality Engineer

This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity.

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

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.

Essential Duties and 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.

Education

- Bachelor’s degree in Engineering, Quality, Science, Pharmacy, Statistics, or a related technical discipline, or an equivalent combination of education and relevant experience.

Work 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.

Preferred Knowledge, Skills and Abilities

- 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.

Additional Requirements

- 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.

Travel Requirements

10%: Up to 26 business days per year
## Physical Requirements

Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.
## What We Offer

- This is an onsite position requiring the team member to be onsite 5 days a week.

- No relocation is provided for this opportunity.

- Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.

- Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.

- Global Career Opportunities: With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration.

- Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.

- Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [email protected] . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.