Job Title: Sr Supplier Quality Engineer
Location: This position is based in our Campbell, California offices. This position is full time.
Why Imperative Care?
Do you want to make a real impact on patients? Imperative Care is changing the way stroke is treated. As part of our team, you’d be developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do.
What You’ll Do
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.- 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 Today.
Salary 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 The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.
Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.