We are seeking a Manager, Quality Assurance - New Product Introduction for our Neurovascular division. This is a hybrid position based two to three days per week in our Salt Lake City, UT office.
As the Manager, Quality Assurance – NPI, you will serve as a global leader and strategic partner within the NPI Quality organization. This role champions design for manufacturability and assembly, providing technical leadership to ensure new products, processes, and technologies are introduced with robust process risk management and high‑quality outcomes. You will guide the team in driving preventative quality, strengthening process capability, and enabling successful, compliant product launches.
Lead the execution of NPI quality strategy to develop capable, scalable manufacturing processes and high‑yield product launches.
Drive robust pFMEA, CQA identification, process validation, process capability, and supplier capability to ensure accurate risk identification and strong process controls.
Oversee implementation of production and process controls, inspection strategies, and test method validations to support high-quality, low‑cost product introductions.
Partner cross‑functionally with Design, Advanced Operations, GQO, and suppliers to strengthen collaboration, share best practices, and harmonize global NPI QA processes.
Coach, develop, and empower NPI QA team members, ensuring strong technical capability, metrology expertise, and performance management practices.
Build organizational capability through optimized, lean inspection approaches, automation opportunities, supplier certification, and technology‑enabled improvements.
Monitor and influence quality performance indicators (supplier DPM, RFT, manufacturing loss, complaints, recalls) and identify opportunities for continuous improvement.
Ensure adherence to corporate, GQO, and external regulatory requirements (including FDA and global standards), supporting high-quality design transfers and compliant product launches.
What You Need
Required
Bachelor’s Degree in Engineering, Science discipline or equivalent
Minimum of 8 years’ experience in medical device, pharmaceutical, biomedical, aerospace, automotive or other regulated manufacturing environments
Minimum of 2 years’ experience and a proven track record of successfully building, managing, and developing a highly talented, engaged and performing team
Expert working knowledge of regulatory requirements, standards, and regulations, with experience of managing inspections/audits by the FDA and other regulatory bodies
Proven ability to build trust, navigate cross‑functional relationships, and advocate for quality in a technical environment
MBA or background in Business Management
Proficiency in quality tools such as SPC, FMEA, RCA, Poka‑Yoke, and Six Sigma methodologies
Experience across multiple quality roles, sites, or functions
Expertise in metrology, GD&T, and interpretation of complex engineering drawings