Senior Quality Engineer
Title: Senior Quality Engineer
This position is based in our Campbell, California offices.
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
Provide Quality Engineering support in the development, manufacture, and distribution of Imperative Care’s medical device products consistent with the Company’s Quality Policy and Quality Objectives. Establish and maintain quality assurance standards that adhere to ISO 13485, FDA and other governmental regulations.
- Support quality incoming inspection and manufacturing of Imperative Care products and ensure conformance to the Imperative Care Quality Management System, FDA QSR, ISO standards, and other regulatory requirements
- Support new product introduction (NPI) activities with product design transfer efforts and reviewing/approving plans and reports
- Provide subject matter expertise of one or more of the following areas: external/internal audits, design of experiments, process validations, statistics, test method validations, risk management, measurement system analysis, sterilization validations, biocompatibility
- Serves as the quality expert for assigned programs and is responsible for making strategic quality decisions throughout the product lifecycle. Provides a proactive front-end approach to product quality.
- Actively monitors product metrics and signals (e.g. cpk /stability, etc.) and initiates/supports improvement projects to enhance performance and /or mitigate quality or compliance risks across products
- Leads investigations in response to quality signals/complaint trends and CAPAs. Actively gathers necessary cross-functional SMEs and leads team to resolve.
What will you bring?
- Experience leading process issues (CAPAs, NCMR/NCRs)
- Must have strong knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 ,and manufacturing processes
- BS in Engineering or related discipline and 5+ years of related experience; or MS in Engineering with 3+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry Experience with development and validation of test methods to comply with recognized standards Must have experience with catheters, endovascular or neurological devices
- Must have demonstrated the ability to perform multiple tasks concurrently with accuracy
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! Imperative Care
Salary: $110,000 - 120,000 annually
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.