Senior Quality Engineer, Integrated Systems

Overview

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per 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.

• 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.
• Global Career Opportunities:
  With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration.
• Recognition & Rewards:
  Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.

In this role, you will provide quality direction, governance, and Quality Management System (QMS) best practices across the programs you support. This role oversees multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment. You may supervise the daily activities of the customer program Quality Engineers responsible for planning, scheduling, executing and communicating all items regarding quality issues, complaints, validations and other projects in support of Customer Program Operations and product release.

You may ensure suppliers deliver products which comply with requirements and specifications. You may lead efforts to enhance the supply chain by addressing supplier and customer issues, improving quality processes internally and with suppliers, and executing quality strategies. You may play a key role in developing and maintaining quality engineering methodologies, collaborating with cross-functional teams, guiding technical evaluations, and implementing improvements in the QMS.

• Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria. Gain buy-in from project team and ensure an inclusive approach to project planning. Proactively identify gaps and risks to project success and implement mitigation strategies to minimize impact.
• Collaborate with cross-functional teams, internal and external to the laboratory, to coordinate project execution and ensure that project objectives and success criteria are met.
• Provide Quality Engineering direction to multiple concurrent product development programs to ensure product and process compliance to all applicable regulatory and cGMP requirements, including ensuring all relevant safety procedures are employed.
• Support the certification efforts to transition the Integrated Systems Laboratory to be accredited for ISO 17025, by completing a gap assessment, identification of actions, and managing the completion of the actions.
• Author, review, and/or approve design history documentation and design manufacturing documentation (e.g., product specifications, design verification and validation activities, FMEA…