Sr Supplier Quality Engineer

Imperative Care•Campbell, CA

1d•Onsite

About The Position

As a senior quality professional, this role provides Quality Engineering support (may focus on product or supplier quality) across the development, manufacture, and distribution of Imperative Care’s medical device products. This position applies to Quality Engineering principles to ensure compliance with applicable regulations (FDA, ISO 13485) and internal Quality System requirements, while driving continuous improvement across either product or supplier performance.

Requirements

Bachelor’s degree in business engineering or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and experience.
Demonstrated knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards (ISO 14971) and good manufacturing practices
Excellent communication skills (both written and verbal)
Proven ability to provide thorough and meticulous review of documents
Proven ability to write clear, concise, and well thought out technical documentation with focus on failure investigations and inspection procedures

Nice To Haves

Advanced degree and experience with catheters, endovascular/neurological devices is highly desired
Experience in medical devices (catheters, endovascular, or neurological) preferred.
Experience in both product and supplier quality engineering strongly preferred.
Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc)

Responsibilities

Collaborate with suppliers, contract manufacturers, and business partners to ensure robust materials, components, and processes.
Lead supplier qualification, audits, requalification, and supplier quality agreement activities.
Own and drive Supplier Quality projects, initiatives, and continuous improvement efforts.
Partner with Procurement, R&D, Operations, and Supply Chain to resolve supplier-related issues and prevent disruptions.
Monitor supplier performance metrics, identify risks, and drive improvement actions.
Manage supplier corrective action processes (SCARs), including tracking, aging metrics, and effectiveness.
Support and/or lead supplier-related CAPAs, NCRs/NCMRs, and investigations.
Conduct deep failure analysis on supplier components and drive root cause and corrective actions.
Implement and manage supplier change control processes, including impact assessment and approvals.
Lead component and supplier qualification and change projects.