Must haves:
Description of Work:
Generates, reviews, and maintains quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
Initiates Change Controls and Document Change Requests to update procedures and processes.
Works within departments and with various departments to update processes and procedures.
Assists in managing the document review and retention processes.
Supports or leads continuous improvement initiatives for document control related processes.
Supports other Quality Assurance functions as needed (internal audit, CAPAs, etc.)
Other duties as required
Minimum Qualifications:
2+ years related experience required. Associate or bachelor’s degree in life sciences, engineering, or a related field preferred. Prior experience in a manufacturing environment is preferred.
Skills/Experience:
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