QMS Compliance Specialist

Dynaflex Technologies Inc.; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality Assurance

Quality Systems

Document Control

CAPA

Complaint Handling

Microsoft Excel

Microsoft PowerPoint

Data Analysis

Cross-functional Collaboration

Ownership/Proactive

Tools

eQMS

QCBD

Job description

Are you organized, proactive, and the kind of person who loves turning to-do lists into done lists?

If you enjoy taking ownership, keeping things on track, working with different teams, and making sure nothing falls through the cracks, we'd love to hear from you!

We're looking for aQMS Compliance Specialistto help keep our Quality Management System running smoothly in a regulated medical device manufacturing environment. This is an opportunity for someone who enjoys variety, thrives on follow-through, and takes pride in getting things done right.

What You'll Do

You’ll help coordinate key quality processes, including document and change control, CAPA, complaint handling, and QMS training. From tracking deadlines and following up with process owners to reviewing records, preparing reports, and supporting audit readiness, you’ll help ensure activities move forward and compliance requirements are met.

You’ll work with colleagues across departments, helping close gaps, keep commitments on track, and make everyday quality processes run more smoothly. This role is more than maintaining paperwork-it’s about bringing organization, visibility, and accountability to the work that keeps our QMS effective.

You Might Be a Great Fit If You…

• Take initiative and follow tasks through to completion without constant reminders.
• Are organized, detail-oriented, and comfortable managing multiple prioritiesin a fast-paced environment.
• Communicate confidently and can follow up with others to keep work moving.
• Enjoy solving problems, closing open items, and finding ways to work more effectively.
• Understand the importance of accurate records and consistent processes in a regulated environment.

What You'll Gain

You’ll be part of a close-knit Quality team where your contributions arevisibleand your work makes a difference. In a collaborative environment, you’ll have opportunities to takeownership, work across different quality processes, and see the impact of your efforts firsthand.

What You’ll Bring

• At least 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 witheQMSis required. Experience withQCBD is a plus.