Staff Quality Engineer

Job Title: Staff Quality Engineer

Location: This position is based in our Campbell, California offices. This position is On-site and 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

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.

• Provide tactical support to execute changes to product throughout the product development lifecycle to comply with regulatory and internal quality system requirements.

• Provide Quality Engineering support for the development of products including:

• oversight and participation in the design control system

• oversight of the Risk Management Report process and participation in the development of Use Risk, Design Risk and Process Risk documentation.

• the development and execution of Quality Plans.

• Lead quality team member for the execution of pilot production of new products and product improvement projects.

• Aid and educate peers on the use of procedures and ensure compliance and timeliness of the output records of the procedures.

• Support supplier quality activities: working with suppliers, develop Quality Agreements and corrective action plans to correct any process failings and drive improvement in quality. Assist in supplier qualification activities including supplier on-site audit and evaluation.

• Maintain Quality Systems, including pre-production QA procedures, pre-clinical testing programs, and postproduction Quality System compliance in coordination with Doc Control, Clinical, Operations and R&D functions.

• Review DCOs involving product or process changes to ensure consistency with company procedures and quality system requirements.

• Assess DCOs, complaints, CAPAs and NCMRs for new or revised risks as part of the oversight of the risk management system.

• May conduct benefit-risk evaluation on product throughout the product development lifecycle, and escalate unacceptable risks to management.

• Support sterilization qualification and biocompatibility projects.

• Assist Regulatory Affairs department in preparation of regulatory submissions as required.

• Complete projects (including product enhancements) in an aggressive manner consistent with corporate objectives. Determine day-to-day tasks in accordance with overall project plan.

• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to Company products.

What You'll Bring

• BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience.

• Must have experience with catheters, endovascular or neurological devices

• Must have demonstrated ability to perform multiple tasks concurrently with accuracy

• Experience leading supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.)

• Must have strong 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)

• Must be able to provide thorough and meticulous review of documents

• Must be able to write clear, concise, and well thought out technical documentation with a focus on failure investigations and inspection procedures

• Must be able to perform multiple tasks concurrently with accuracy

• Proficiency with Microsoft Office products

• Ability to communicate effectively, both orally and in writing, with all organizational levels

• Strong attention to detail and ability to function in a fast-paced dynamic environment

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: $148,000 - 155,000 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.