The Sr Quality Engineer ensures the quality of medical device products through validation processes, data analysis, regulatory compliance, and collaboration with teams and suppliers.
Job Title: Sr 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 professional in this field, this position will use solid knowledge and experience and contribute to the development, manufacture, and distribution of Imperative Care’s medical device products by applying Quality Engineering principles to all applicable processes and procedures in accordance with the Company’s Quality Policy and Quality Objectives.
What You’ll Bring
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 – 130,000/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.
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 professional in this field, this position will use solid knowledge and experience and contribute to the development, manufacture, and distribution of Imperative Care’s medical device products by applying Quality Engineering principles to all applicable processes and procedures in accordance with the Company’s Quality Policy and Quality Objectives.
- Provide quality input to define required validations necessary to support significant process changes on commercially launched products.
- Collaborate with team members to define validation requirements, specifications, testing, and component/product acceptance activities.
- Analyse data by completing hypothesis, normal distribution, and process capability analysis tests intended to provide input on the quality of the product/process being evaluated/monitored.
- Create and revise quality assurance procedures, as required, to maintain compliance to changing regulations and guidance documents.
- Train broad audience on the use of procedures to comply with Quality Systems and Regulations.
- Serve as liaison with laboratories conducting routine product testing or root cause analysis related to testing failures or deviations.
- Conduct methodical root cause investigations and provide guidance to prevent recurrence.
- Work with suppliers to qualify and maintain approved supplier status. May evaluate supplier notification of change and recommend necessary actions to maintain compliance.
- Perform statistical analysis of manufacturing data and quality processes and creation of reports based on quality documentation.
- Review DCO’s involving product or process changes to ensure consistency with company procedures and quality system compliance.
- Conduct and review Risk Management assessments on product and process changes.
- Conduct failure mode effect analysis on product.
- Support projects (including product enhancements) in an aggressive manner consistent with corporate objectives.
- May provide quality metric data to various functional groups within the organization.
What You’ll Bring
- Bachelor’s degree in engineering, or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and work experience
- Advanced degree and experience with catheters, endovascular/neurological devices is highly desired.
- 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 communications 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.
- Strong ability to perform multiple tasks concurrently with accuracy.
- Proficiency with Microsoft Office products.
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 – 130,000/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.
Top Skills
Fda 21 Cfr Part 820
Iso 13485
Iso 14971
Iso 9001
MS Office
Quality Engineering Principles
Imperative Care Campbell, California, USA Office
Dell Ave, Campbell, CA, United States, 95008
Similar Jobs
Aerospace • Hardware • Robotics • Software • Manufacturing
The Senior Build Quality Engineer will enhance quality processes in the Terran R rocket program, collaborating with design and manufacturing teams to implement standards and improve reliability.
Top Skills:
ErpGd&TMesPlmQms
Healthtech • Information Technology • Mobile • Productivity • Software • Analytics • Telehealth
The Senior Mobile QA Engineer will perform black-box testing for mobile and web applications, create test plans, and improve QA processes, collaborating with various teams to deliver quality software.
Top Skills:
Ai/LlmAndroidCharlesiOSProxymanRepeatoSQLWaldo
Aerospace • Artificial Intelligence • Hardware • Robotics • Security • Software • Defense
As a Supplier Quality Engineer, you will enhance quality in avionics components, collaborate with design teams, manage supplier performance, and ensure compliance with standards.
Top Skills:
As9100CanDo-160Do-178CDo-254EthernetFbgasI2CIpc-A-610Ipc-A-630Iso 9001JmpLattice OsMatlabMicrocontrollersMil-Std-810MinitabPc-J-Std-001PcbPcbaPcieSpiUsb
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
- Number of Tech Workers: 365,500; 13.9% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Google, Apple, Salesforce, Meta
- Key Industries: Artificial intelligence, cloud computing, fintech, consumer technology, software
- Funding Landscape: $50.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Sequoia Capital, Andreessen Horowitz, Bessemer Venture Partners, Greylock Partners, Khosla Ventures, Kleiner Perkins
- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
