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Redbock - an NES Fircroft companyFremont, CA, United States
6 days ago
Job description
SUMMARY :
We are seeking a skilled Quality Assurance Engineer to join our innovative team dedicated to advancing medical device technologies. In this role, you will play a crucial part in ensuring the quality and compliance of our products throughout their development lifecycle.
DUTIES & RESPONSIBILITIES :
Design, document, and conduct thorough reviews of product designs.
Engage in component and product Quality Assurance / Design Assurance processes.
Create and manage documentation that meets ISO 13485 and 21 CFR 820 standards.
Perform additional responsibilities as needed to support the team.
QUALIFICATIONS & REQUIREMENTS :
A minimum of 3 years of experience in medical device quality assurance related to new product development and lifecycle management.
Strong understanding of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate), as well as 21 CFR 820 and ISO 13485.
Practical experience conducting quality inspections on components, subassemblies, or finished products.
Experience in reviewing design documentation, including drawings, specifications, DHFs, and test data sheets.
Preferred Qualifications :
Familiarity with risk management files, such as FMEAs and hazard analyses, along with a solid understanding of ISO 14971 : 2019.
Previous experience managing Non-Conformity Reports (NCRs) and Corrective and Preventive Actions (CAPAs).
LOCATION :
This position is located at our headquarters. Please note the exact address will be provided during the recruitment process.