QMS Compliance Specialist - Drive Audit Readiness

Dynaflex Technologies Inc.; Irvine (CA); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Dynaflex Technologies Inc. is seeking a QMS Compliance Specialist to help keep our Quality Management System running smoothly in a regulated medical device manufacturing environment.

The role emphasizes ownership, follow-through, and cross-functional collaboration to ensure compliance and continuous improvement. You’ll coordinate document and change control, CAPA, and complaint handling while supporting QMS training and audit readiness.

Formación

• 3+ years of relevant experience in Quality Assurance, Quality Systems, document control, CAPA, complaint handling, or a related function in medical device manufacturing.
• Working knowledge of ISO 13485 and FDA QMSR requirements.
• Strong proficiency in Microsoft Office, particularly Excel and PowerPoint, with the ability to organize and analyze data, prepare reports and metrics, and create clear, professional presentations.
• Strong organizational, communication, follow-up, and problem-solving skills, with the ability to manage multiple priorities independently and collaborate effectively across departments.
• A proactive, results-oriented mindset and the ability to take ownership of assigned activities and drive them to completion.
• Experience with QMS is required. Experience with QCBD is a plus.

Responsabilidades

• Coordinate key quality processes, including document and change control, CAPA, complaint handling, and QMS training.
• Track deadlines and follow up with process owners, review records, prepare reports, and support audit readiness.
• Help ensure activities move forward and compliance requirements are met.
• Work with colleagues across departments to close gaps, keep commitments on track, and improve everyday quality processes.

Conocimientos

Quality Assurance

Quality Systems

Document Control

CAPA

Complaint Handling

Microsoft Excel

Microsoft PowerPoint

Data Analysis

Cross-functional Collaboration

Ownership/Proactive

Herramientas

eQMS

QCBD

Descripción del empleo

Dynaflex Technologies Inc. is seeking a QMS Compliance Specialist to help keep our Quality Management System running smoothly in a regulated medical device manufacturing environment.

The role emphasizes ownership, follow-through, and cross-functional collaboration to ensure compliance and continuous improvement. You’ll coordinate document and change control, CAPA, and complaint handling while supporting QMS training and audit readiness.