We are seeking a detail-oriented and proactive Document Control Clerk to join our innovative and high-performing team. This position is critical in managing both paper and electronic documents to ensure compliance with quality system requirements and regulations. The Document Control Clerk will play a key role in the Quality team, ensuring that documents and records are meticulously maintained.
Responsibilities
Prepare Document Change Orders (DCO) using the company's electronic system.
Review and ensure completeness of records and manage filing (both physical and electronic).
Manage and update training records, training plans, and database entries.
Review Device History Records (DHR) for compliance with manufacturing and inspection procedures, equipment settings, calibration requirements, material usage, inspection results, and good documentation practices.
Assist the Quality Assurance Specialist with equipment calibration and preventive maintenance, including collecting equipment, making database entries, and sending email notifications.
Scan and file paper records both electronically and in physical file cabinets.
Skills & Hands-On Experience
Proficient in Microsoft Office Suite (Word/Excel) and Adobe Acrobat (PDF editing).
Experience with SolidWorks is preferred.
Strong communication and interpersonal skills.
Ability to thrive in a fast-paced environment.
Education & Work Experience
AA degree preferred.
Minimum of 2 years of relevant experience in document control or a related field.
Previous experience in the medical device industry is preferred.