Quality Documentation Coordinator

About the role

This role is responsible for releasing finished goods through Oracle following review and approval of appropriate documents, ensuring product quality and regulatory compliance. The position manages nonconforming products through QA hold processes, conducts final reviews of production and sterilization records, releases finished goods through Oracle, maintains DHR and outsourced sterilization documentation, and generates required quality certificates. The role also supports compliance with applicable laws, regulations, standards, and company procedures. Additional responsibilities are performed as assigned by the supervisor. This is an Entry-Level role based on-site at the Dublin, Ohio manufacturing facility.

Responsibilities

• Maintain control of non-conforming products through the QA hold process.
• Perform final quality review of all production and sterilization documentation prior to product release.
• Release all conforming finished product through Oracle.
• Perform filing of Device History Records (DHR).
• Generate Sterility and Certificate of Conformance letters.
• Review documentation and release of outsourced sterile product and maintain files.
• Maintain control of non-conforming products through Oracle QA hold.
• Assure compliance of company operations to all applicable laws, regulations, standards, good business practices, and company documented procedures, including knowledge of standards, government occupational health, and environmental regulations and statutes related to the site.

Requirements

• High School Diploma or equivalent.
• 1–2 years of administrative or clerical experience preferred.
• Microsoft Office experience strongly preferred.
• Previous Oracle experience preferred.
• Previous medical device knowledge preferred.
• Familiarity with regulatory standards such as ISO 13485 and FDA requirements.
• Excellent written and oral communication skills.
• Strong interpersonal skills and ability to work closely in a team environment.
• Ability to multitask and work effectively in a fast-paced, dynamic environment.
• Basic math skills.

Physical Requirements and Work Environment

• Must be able to perform essential job functions in an office environment.
• Long periods of sitting to enter and analyze data are expected.
• Adequate manual dexterity to operate standard office equipment.
• Ability to occasionally lift objects up to 25 lbs.