West Pharmaceutical Services · 2 hours ago
Senior Manager, Quality Engineering
US Arizona Scottsdale
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expWest Pharmaceutical Services is a dedicated team focused on improving patient lives in the healthcare industry. The Senior Quality Engineering Manager provides strategic and technical leadership for the Quality Engineering function, ensuring compliance with quality systems and driving excellence in product and process quality.
BiotechnologyHealth CareIndustrialManufacturingPackaging ServicesPharmaceutical
Responsibilities
Lead and mentor a team of Quality Engineers to ensure consistent delivery of high-quality products that meet or exceed customer expectations
Foster professional growth through coaching, targeted training, performance feedback, and individual development plans
Recruit, develop, and lead high-performing Quality Engineering talent; build organizational capability through mentorship, performance management, and succession planning
Serve as a quality champion across the organization, influencing design, engineering, and manufacturing decisions to embed quality principles from concept through commercialization
Align Quality Engineering priorities with operational and business objectives to achieve strategic alignment
Develop strong cross-functional partnerships with Design Quality Engineering, R&D, Manufacturing, Operations, Corporate Quality, and Supply Chain teams to drive alignment and performance
Collaborate with customers to maintain compliance and strengthen quality partnerships
Ensure Quality Systems are compliant with regulatory and company standards (ISO 13485, 21CFR, EU MDR)
Review, approve, or author quality documentation, including investigations, SOPs, validation protocols/reports, and device master records
Evaluate, design, and optimize production and process control strategies to achieve both quality and plant objectives
Serve as a Subject Matter Expert during internal and external audits and contribute to audit readiness and execution
Drive continuous improvement initiatives through process optimization, data analytics, and adoption of quality tools and technologies
Develop and implement strategies to control costs, mitigate risks, and enhance productivity while maintaining compliance
Evaluate and implement changes to continuously improve the Quality Management System (QMS), ensuring scalability and effectiveness
Define, monitor, and analyze key Quality metrics (KPIs) to assess performance, compliance, and identify improvement opportunities
Keep current with emerging technologies, regulations, and best practices to ensure proactive compliance and innovation in quality systems
Perform other related duties as assigned in support of quality, operational, and business objectives
Qualification
Required
Bachelor's Degree in a related field, such as Engineering or Science, required
Minimum 10 years of related experience in the Medical Device/GMP industry required
Knowledge of Medical Device Regulatory Requirements and MD Standards: 21 CFR Part 820, EU/MDR, ISO 13485, ISO 14791, GMPs, GDP
Preferred
Master's Degree with an emphasis in Engineering, Science, or Business
Minimum 5 years of People Management experience
Minimum 5 years of experience working with validations, pFMEA, Risk Management, Root Cause Methodology, CAPA, MSA, Lean Manufacturing, Six Sigma, auditing processes, and project management
Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of customer visits and business development related activities
Strong knowledge and experience in Quality Systems in Medical Devices/Pharmaceuticals
Demonstrated people skills specific to team building, problem solving and conflict resolution
Project management experience and ability to present project's progress to upper management
Excellent presentation, writing, verbal, computer, interpersonal and communication skills
Ability to adapt to frequent changes, unexpected events and still yield an effective outcome
Manages competing demands, makes timely and sound decisions, even under conditions of risk
Accepts feedback from others, ability to engender enthusiasm, motivate peers and subordinates and teambuilding
Support and contribute to Lean Sigma programs and activities towards delivery of the set target
Lean Six Sigma Black Belt certification
CQA/CQE certification
Benefits
Generous Paid Time Off (PTO)
Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.
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.
Company
West Pharmaceutical Services
West Pharmaceutical Services is a manufacturer of technologically advanced containment and delivery systems for injectable medicines.
5001-10000 employees
H1B Sponsorship
West Pharmaceutical Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (24)
2023 (18)
2022 (26)
2021 (17)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Eric Green
Chairman, President, and CEO
Atul Patel
Vice President, Devices & Delivery Systems
Recent News
2026-01-20
Company data provided by crunchbase