Sr. Quality Engineer, Design Quality

Onsite position with hybrid opportunities in Scottsdale, AZ.

 

Who We Are:

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, the Senior Quality Engineer, Design Quality provides quality leadership, governance, and engineering best practices to medical device, combination product, and containment product development programs.  This is a global role that will oversee multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the development lifecycle into manufacturing and sustainment.  The incumbent will provide quality leadership for development projects from product inception through design transfer including partnering with Operations to establish and qualify / validate the manufacturing process as part of NPI.  This role will ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements according to the intended distributed markets. 

They will partner with R&D, Regulatory, Supplier Quality, and Operations to establish consistency across product platforms, drive engineering design improvements, and lead implementation of design control related strategies and objectives.  This role will drive harmonization and alignment of West design control methodologies and processes across product platforms, sites, and teams to ensure consistency and state-of-the-art Design History Files. 

The incumbent will be a strong advocate for product, process, and system quality at all stages of product realization.  Additionally, this role will identify and implement improvements within the Global Enterprise Quality Management System as part of continual improvement and global objectives. 

 

Essential Duties and Responsibilities:

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Provide Quality Engineering oversight and direction for multiple concurrent product development programs to ensure product & process compliance to all applicable regulatory and cGMP requirements.
• Provide leadership on the product development process, process validation/qualification, and compilation of design related technical and engineering product and process documentation.  Partner with R&D teams to implement strategic platform product development approaches to product development.
• Author, review, and/or approve DHF documentation (e.g., strategic planning, product specifications, design verification & validation activities, risk management activities, test method validations, protocols, reports, product transfer to operations, etc.) 
• Provide quality oversight, review, and approval of qualification documentation and reports.  Provide direction during technical and design review activities as a Design Quality SME.  Provide Quality oversight of qualification/validation/design controls activities to other QEs.  Review the quality of work completed with the project team to ensure it meets project standards.
• Lead the development and maintenance of product or process risk and hazard analysis in accordance with West policies and procedures.
• Ensure the applicable development phase requirements are sufficiently fulfilled and documented within the DHF before allowing the project to proceed within the development process.  Escalate and prevent the progression of product development, including release of clinical product, if warranted.
• Partner with Operations and Operations Quality during design transfer to ensure product DMR and knowledge transfer is complete and effective.
• Represent West Quality as the primary interfacing Design Quality SME with customers to ensure strong partnershi