Imperative Care · 2 days ago
Quality Assurance Specialist II
Campbell, CA
Full-time
Onsite
Entry Level
$85K/yr - $91K/yr
1+ years expImperative Care is dedicated to elevating care for patients suffering from stroke and other vascular diseases. The Quality Assurance Specialist II will work with cross-functional teams to maintain the Quality System in compliance with regulatory requirements, support quality management activities, and assist in document control processes.
Health CareMedicalMedical Device
Responsibilities
Support company policies and procedures to ensure the Quality Management System and regulatory compliance requirements are entered, maintained and monitored
Identify gaps, enhancements and revise/improve forms, work instructions, and procedures to maintain quality compliance
May assist in conducting investigations and root cause analyses and provide recommendations for corrective and preventive action plans for identified issues
Provide support during internal and external audits
Assist/maintain quality metric reports, as defined by management
Assist in updating the Approved Supplier List based on the results of the supplier evaluation form
Assist in the maintenance of the approved supplier list and supplier files, including updating of supplier certifications and coordination of requalification activities
Review batch records to support release of raw materials, subassemblies, and final products. File and maintain batch records current
Review proposed document changes, coordinate with change initiators/reviewers to address redlines and feedback, review change orders for accuracy and completeness
Collect and provide trending data on document processing metrics
Responsible for the administration activities related to document control system
Maintain and implement electronic and hard copy logs tracking externally referenced documents and standards and tracking the locations of controlled documents
Qualification
Required
Bachelor's degree in related field and a minimum of 1 years of work experience; or equivalent combination of education and work experience
Working knowledge of quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), and good manufacturing practices
Excellent communications skills (both written and verbal)
Ability to provide thorough and meticulous review of documents
Ability to perform multiple tasks concurrently timely with accuracy and organized
Proficient in Microsoft Office products
Benefits
Stock options
Competitive salaries
Bonus
A 401k plan
Health benefits
Generous PTO
A parental leave program
Emotional health resources
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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (3)
2023 (5)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$558.97MKey Investors
Ally Bridge GroupD1 Capital Partners
2024-07-25Series E· $150M
2021-07-15Series D· $260M
2021-01-01Debt Financing· $40M
Leadership Team
Lara Abbaschian
Senior Director, R&D
Recent News
BioWorld Financial Watch
2025-09-24
Company data provided by crunchbase