Quality Engineer II

Campbell, CA

Full Time

Quality

Mid Level

Title: Quality Engineer II
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?
As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do.

What You’ll Do
As a Quality Engineer II, the person in this position will provide 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.

Assist with on-site manufacturing line support, verifying equipment and processes follow predetermined quality standards.
Collaborate with team members to define validation requirements, specifications, testing, and component/product acceptance activities.
May analyze data by completing hypothesis, normal distribution, and process capability analysis tests.
May 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.
Assist with investigating problems reported and developing improvement methods and processes to overcome them.
Support supplier quality and contract manufacturing sites by addressing actions necessary to resolve quality performance issues.
May conduct statistical analysis of manufacturing data and quality processes and creation of reports based on quality documentation
May review DCOs involving product or process changes to ensure consistency with company procedures and quality system compliance.
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.
Complete projects (including product enhancements) in an aggressive manner consistent with corporate objectives. Determine day-to-day tasks in accordance with overall plan.

What You’ll Bring:

Bachelor’s degree in Engineering or related discipline and 1+ years of related experience or equivalent combination of education and work experience.

Experience working under Medical Device quality system requirements and Regulations and good manufacturing practices highly desired
Knowledge and exposure to data collection and statistical analytics methods
Excellent communications skills (both written and verbal), with all organizational levels
Excellent 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!

Salary Range: $90,000 – 101,000 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. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.

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