Quality Engineer I

Job Title: Quality Engineer I

Location: This position is based in our Campbell, California offices. This position is on-site &  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

This position provides Quality Engineering support in the development, manufacture, and distribution of Imperative Care Vascular’s medical device products consistent with the Company’s Quality Policy and Quality Objectives. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Initiate and maintain continuous improvements for finished goods lot inspection and release process.
• Assist in development and review of manufacturing processes, Manufacturing Process Instructions (MPI’s) and Lot History Records (LHR’s) in collaboration with Manufacturing and R&D
• Actively support development of manufacturing specifications for products; coordinate all process validation activities - IQ/OQ/PQ.
• Assist with line support, verifying equipment and processes at contract manufacturers and follow predetermined quality standards.
• Collaborate with contract manufacturers and team members to define validation requirements, specifications, testing, and component/product acceptance activities.
• Support new product introduction (NPI) activities with product design transfer efforts and reviewing/approving plans and reports
• Analyze data by completing hypothesis, normal distribution, and process capability analysis tests. 
• Conduct statistical analysis of manufacturing data and quality processes.
• Actively monitor product metrics and signals (e.g. cpk /stability, etc.) and initiate/support continuous improvement projects to enhance performance and /or mitigate quality or compliance risks across products. Compile and analyse measurement and testing data results using Excel, Mini-Tab, or other statistical software. Support supplier quality by addressing actions necessary to resolve quality performance issues. 
• Revise quality assurance procedures and/or provide training on the use of the procedures to promote compliance with Quality System and Regulations to a broad audience.
• Create, review and revise DCO’s involving product or process changes to ensure consistency with company procedures and quality system compliance.
• Participate in root cause investigations in response to quality signals/nonconformance/complaint trends and CAPAs. Actively seeks advise from necessary cross-functional SMEs and leads to find an effective solutions.
• Support Risk Management assessments on product and process changes.
• Support company goals and objectives, policies and procedures, Good Manufacturing practices, and applicable FDA and other Regulatory agency requirements.

What You’ll Bring

• BS in Engineering or related discipline
• Less than 2 years of professional experience, non-related experience considered; or equivalent combination of education and work experience.
• Medical device, related regulated industry, or endovascular/neurovascular techniques/experience is a plus
• Statistical analysis Software (Minitab or similar), CAD (Solidworks, similar), and proficiency with Microsoft Office products is a plus
• Desire to acquire experience working under regulated quality systems such as GMPs, ISO 13485, etc.
• Must be willing and able to travel 25% of the time domestically and internationally

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.

Salary Range: $78,000 - $83,000 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.

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