Job Title: Sr Supplier Quality EngineerLocation: This position is based in our Campbell, California offices. This position is full time.
What You'll DoAs 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.
- 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.
What You'll Bring- 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.
- 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)
- 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
Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.
Join Us! Apply TodaySalary Range: $120,000 -151,000
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer.
The posted salary range reflects compensation for employees based in the local Bay Area market. For candidates hired outside of this geographic area, compensation may vary and be adjusted based on location, local market conditions, and other factors
