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Imperative Care · 5 days ago
Staff Quality Engineer
Campbell, CA
Full-time
Onsite
Senior Level
$148K/yr - $155K/yr
8+ years exp
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Responsibilities
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.
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 the overall project plan.
Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to Company products.
Qualification
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Required
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
Benefits
Stock options
401k plan
Health benefits
Generous PTO
Parental leave program
Company
Imperative Care
Imperative Care is singularly dedicated to finding meaningful answers to unsolved problems in stroke.
201-500 employees
H1B Sponsorship
Imperative Care has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (5)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$408.97MKey Investors
D1 Capital Partners
2021-07-15Series D· $260M
2021-01-01Debt Financing· $40M
2019-12-10Series C· $85M
Leadership Team
Lara Abbaschian
Senior Director and R/D
Recent News
2024-06-04
2024-06-04
GlobeNewswire
2024-06-04
Company data provided by crunchbase
