Senior Manager, Quality Engineering

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

 

Who We Are:

 

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.  

What We Offer

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.

Job Summary

The Senior Quality Engineering Manager provides strategic and technical leadership for the Quality Engineering function within a regulated medical device manufacturing environment. This role is responsible for leading a team of Quality Engineers and driving excellence in product and process quality from design through commercialization. The manager ensures all quality systems comply with ISO 13485, FDA 21 CFR, and EU MDR requirements, while partnering closely with Operations, Engineering, R&D, and Supply Chain to align quality objectives with business goals. This role will lead process improvement initiatives, strengthen quality management systems, and champion a culture of continuous improvement and collaboration. This position plays a key role in risk reduction, compliance assurance, and delivery of safe, effective, and high-quality products that meet or exceed customer expectations.

Essential Duties and 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 practic