Document Control Specialist (Medical Devices)

Location: Audubon, Pennsylvania, United States

Company

hirify.global develops medical-device solutions designed to improve surgical techniques and outcomes for patients with musculoskeletal disorders.

What you will do

• Issue, maintain, control, audit, and distribute quality-system, device master record, and other technical documents.
• Process Document Change Orders and ensure controlled documentation is complete, correctly formatted, and compliant with corporate standards.
• Coordinate documentation-related training and maintain the Net Dimensions training system.
• Manage new item creation, part-number tracking, bills of materials, routes, and related system data.
• Monitor AX transactions, troubleshoot issues, support functional testing, and implement system improvements.
• Perform database searches, data analysis, and reporting to support product-development and design-engineering activities.

Requirements

• High school diploma or higher and at least two years of progressive work experience, preferably in the medical-device or another regulated industry.
• Ability to review documents for accuracy, perform data entry, and scan and file records.
• Knowledge of Microsoft Word and Excel.
• Experience with planning software and with developing or reviewing its processes and procedures from a functional perspective.
• Strong organizational, typing, analytical, critical-thinking, communication, and writing skills.
• Ability to comply with applicable United States and international laws, regulations, and company standards.

Culture & Benefits

• Work is guided by innovation, customer focus, teamwork, and a driven, results-oriented approach.
• Participation in continuous-improvement activities is expected.
• Training is provided on compliance requirements, documentation practices, and company codes of conduct.
• The role includes physical activities such as sitting, climbing or balancing, crouching, and lifting up to 25 pounds occasionally.
• An inclusive workplace committed to equal employment opportunity and respectful collaboration.