Quality Assurance Specialist II
About The Position
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 developing professional, this position works directly with multiple cross-functional teams to provide support and maintain the Quality System in compliance with requirements of internal procedures, and applicable regulatory requirements. This role will record, review, product release, and share knowledge of document control.
Requirements
- 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.
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
Benefits
- Employee Benefits include a stake in our collective success with stock options, competitive salaries, bonus, a 401k plan, health benefits, generous PTO, and a parental leave program.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
