Job Description

For immediate consideration, please email resume to [email protected]! I will be conducting the phone screen for this role!
Job Title: Quality Engineer
Job Description
This specialized role requires a focus on regulatory compliance, rigorous testing procedures, and meticulous documentation to ensure that relevant products are safe, effective, and meet all relevant standards before reaching customers.
Responsibilities

+ Ensure that all testing processes and product developments comply with relevant medical device regulations such as FDA (21 CFR Part 820) and other international standards.

+ Maintain thorough and accurate records of all testing procedures, results, and corrective actions to comply with regulatory audit requirements.

+ Assist in internal and external audits by regulatory bodies, ensuring all processes meet the necessary compliance standards.

+ Conduct risk assessments to identify potential hazards associated w...

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