Job Description

Must haves:

• Proficiency in Microsoft Office and Excel
• Ability to follow written procedures
• Detail oriented
• Ability to work autonomously

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:

• Previous experience using ETQ or other Document Management software preferred
• Proficiency in Microsoft office
• Experience in ISO 9001 or other Quality System standards
• ISO 13485 and 21 CFR 820 Quality Management Systems knowledge highly preferred
• Must be detail oriented and accurate in execution of work
• Able to work well both independently and in a group setting

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