Quality Design Engineer

Description:

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

In this role you will be the QA Lead to support West proprietary design and development projects. While managing the quality aspects of these projects, you will provide the corresponding teams with guidance on design quality-related issues as well as design control best practice and you will drive a culture of compliance and continuous improvement.

Your Responsibilities:

• You will drive the closure of change controls and protocol deviations
• To manage activities connected to product design and development, you will review and draft procedures and forms
• Acting as the interface between development teams and operational quality, you will perform first article component and products inspections, draft defect libraries and quality inspection documents and manage formal hand over of same to Operational Quality
• In accordance with West supplier management procedures, you will support the supplier selection process
• You will be the person responsible to ensure proprietary design and development projects are executed in compliance with regulations, international standards and enterprise procedures
• In collaboration with proprietary design and development teams, you will facilitate risk assessment meetings
• You will review and approve design history file records, validation documents and metrology data