Medical Device Quality Document Control Specialist

Talentify; Haltom City (TX); Presencial; USD 33.000 - 39.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental & vision

401(k) Retirement Plan

PTO / Paid time off

Descripción de la vacante

Talentify seeks a Quality Assurance Specialist to serve as a regulatory quality resource across Operations and QA in a medical device production setting. The role focuses on ISO and 21 CFR 820 compliance, CAPA, documentation control, and cross-functional collaboration to improve quality systems.

The position is contract-based and onsite in Haltom City, TX, with a competitive pay range and comprehensive benefits for eligible staff.

Formación

• 13+ years in quality assurance or operations.

Responsabilidades

• Analyze quality processes, procedures and documents against ISO standards and 21 CFR 820 regulations to ensure compliance.
• Update corrective actions, including identification of issues, development of corrective action plans, implementation, and follow-up verification.
• Manage and support the complaint handling process, including intake, investigation, documentation, and resolution.
• Validate and improve procedures and work instructions for clarity and regulatory alignment.
• Maintain and revise documentation control processes for controlled, compliant quality documentation.
• Initiate, review, and manage engineering change orders to ensure proper evaluation and implementation.
• Collaborate with cross-functional teams to address quality issues and optimize process flow.
• Coordinate with external auditors, providing documentation and follow-up actions.
• Prepare clear technical reports and investigation summaries detailing findings and actions.
• Background in QA with additional QC experience considered beneficial.
• Experience in medical product manufacturing environments is a plus.
• Practical experience with CAPA processes including action plans and follow-through.
• Technical writing skills for reporting investigations and compliance documentation.
• Ability to validate and refine work instructions for regulatory alignment.
• Understanding of manufacturing processes, process flow, and product testing requirements.

Descripción del empleo

Talentify seeks a Quality Assurance Specialist to serve as a regulatory quality resource across Operations and QA in a medical device production setting. The role focuses on ISO and 21 CFR 820 compliance, CAPA, documentation control, and cross-functional collaboration to improve quality systems.

The position is contract-based and onsite in Haltom City, TX, with a competitive pay range and comprehensive benefits for eligible staff.