Quality Engineer

West Pharmaceutical Services

. Provide technical Quality Engineering support for technology transfer, qualification, validation, manufacturing processes, investigations, risk management, and ongoing commercial production .

Posted 10/2/2026full-timeGreenfield • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Engineering, including process validation, risk management, and compliance with regulatory standards such as ISO 13485 and 21 CFR. Proficient in structured problem-solving and statistical methods to drive continuous improvement in manufacturing processes.

Highest-signal resume keywords

Quality EngineeringProcess ValidationRisk ManagementISO 13485CAPA

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical Process ControlRoot Cause AnalysisDeviation InvestigationsChange ControlProcess CapabilityTechnology TransferNew Product IntroductionQuality SpecificationsControl PlansManufacturing Readiness

Soft Skills

Strong Communication SkillsFlexibilityAdaptabilityResilienceTeam Collaboration

Tools & Technologies

Quality Management SystemsManufacturing Control StrategiesInspection StrategiesDefect LibrariesQuality Agreements

Industry Keywords

PharmaceuticalMedical DeviceCombination ProductsGood Documentation PracticesEU GMP

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Provide technical Quality Engineering support for technology transfer, qualification, validation, manufacturing processes, investigations, risk management, and ongoing commercial production
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
Partner with Operations, Engineering, Validation, Laboratory, Quality Systems, Supplier Quality, and other functions supporting medical device, pharmaceutical packaging, and drug-device combination product programs
Ensure Quality Engineering activities comply with regulatory requirements, corporate policies, procedures, Quality Agreements, 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
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
Translate customer and product requirements, Critical to Quality characteristics, and Quality Agreement responsibilities into 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 and provide QA oversight, ensuring 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 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 Quality independence
Support customer, internal, notified body, and regulatory audits or inspections as a Quality Engineering subject matter expert
Coach cross-functional teams in structured problem-solving, statistical methods, validation, and risk-based decision-making
Report to the Quality Engineering Manager or Quality Operations Manager, as assigned

Requirements

What you’ll need

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
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
Ability to work in a fast-paced, dynamic manufacturing environment
Flexibility, adaptability, and resilience
Willingness to learn new skills, expand responsibilities, and contribute to organizational growth
Ability to meet medium-exerting physical requirements of up to 50 lb/22 kg occasionally, up to 20 lb/9 kg frequently, and up to 10 lb/4 kg constantly
Willingness to travel 10%, up to 26 business days per year
Must work onsite 5 days a week; no relocation is provided

Benefits

Comp & perks

Supported benefit programs promoting the physical, mental, emotional, and financial health of team members and their families
Volunteerism through the West without Borders initiative and other charitable programs
Training programs
Tuition assistance
Leadership development
Skill-certification initiatives
Global career opportunities and international exposure
Cross-functional collaboration
Inclusive and collaborative culture valuing diversity, equity, and inclusion
Performance-based bonuses
Service recognition
Employee appreciation initiatives