Production Documentation Specialist (Medical Devices)

TL;DR

Production Documentation Specialist (Medical Devices): Managing the accurate printing, review, issuance, reconciliation, and database entry of Device History Records for regulated medical-device production with an accent on documentation control, quality systems, and production coordination. Focus on resolving record discrepancies, supporting material investigations, expediting documentation for sterile load dates, and maintaining compliance with domestic and international regulations.

Location: On-site in Salt Lake City, Utah, United States; day shift.

Salary: $20.00–$28.00 per hour ($3,200–$4,480 estimated monthly equivalent).

Company

hirify.global is a global healthcare company that designs, develops, manufactures, and markets innovative medical devices and therapies for challenging medical conditions.

What you will do

• Receive and review production requests and support production control activities.
• Print, verify, issue, review, scan, label, and file Device History Records accurately.
• Enter Device History Record information into databases and verify training records.
• Follow up on documentation discrepancies and material investigations with Production personnel.
• Provide lot status updates, reconcile finished and rejected parts, and help expedite records for sterile load dates.
• Maintain compliance with the Quality Management System and applicable quality regulations, standards, and procedures.

Requirements

• High school diploma or associate degree, or an equivalent combination of education and experience.
• 1–3 years of production systems experience in a regulated medical-device or pharmaceutical environment.
• Strong written and verbal communication skills.
• Strong organizational skills and careful attention to detail.
• Ability to work in office, production, and controlled environments and perform the required standing, walking, reaching, and computer-based activities.

Culture & Benefits

• Collaborative teamwork environment with continuous learning and performance recognition.
• Medical, dental, vision, life, AD&D, short- and long-term disability insurance.
• 401(k) plan with employer match.
• Paid parental leave, eleven company holidays, accrued vacation, and paid sick time.
• Opportunity to contribute to medical technologies addressing serious diseases.