Senior Manager, Quality Engineering
West Pharmaceutical Services
full-time
Posted on:
Location Type: Office
Location: Scottsdale • Arizona • United States
Visit company websiteExplore more
Job Level
About the role
- Provide strategic and technical leadership for the Quality Engineering function within a regulated medical device manufacturing environment.
- Lead and mentor a team of Quality Engineers to ensure consistent delivery of high-quality products that meet or exceed customer expectations.
- 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.
- Ensure Quality Systems are compliant with regulatory and company standards (ISO 13485, 21CFR, EU MDR).
- Drive continuous improvement initiatives through process optimization, data analytics, and adoption of quality tools and technologies.
Requirements
- Bachelor's Degree in a related field, such as Engineering or Science, required.
- Master's Degree with an emphasis in Engineering, Science, or Business, preferred.
- Minimum 10 years of related experience in the Medical Device/GMP industry required.
- Minimum 5 years of People Management experience preferred.
- 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 preferred.
- Lean Six Sigma Black Belt certification preferred.
- CQA/CQE certification preferred.
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Engineeringprocess optimizationdata analyticsvalidationspFMEARisk ManagementRoot Cause MethodologyCAPAMSALean Manufacturing
Soft Skills
leadershipmentoringcross-functional collaborationstrategic alignmentcommunication
Certifications
Lean Six Sigma Black BeltCQACQE