Manager, Quality Operations & Compliance

Company Overview::

Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

 

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

Position Overview::

The Manager, Quality Operations is responsible for overseeing the Quality Management System (QMS) to ensure compliance with FDA regulations (QMSR), ISO standards (e.g., ISO 13485), JPAL, Canadian, ANVISA, Australia requirements and other applicable global regulatory requirements related to MDSAP. This role supports manufacturing operations by implementing quality assurance protocols, managing audits, and driving continuous improvement initiatives to ensure the safety, efficacy, and reliability of medical devices. Performs a variety of activities to ensure compliance with applicable quality and safety standards and regulatory requirements by conducting audits, providing training, and performing data and documentation review. This position has authority to provide QA approval on quality system documents, and to provide QA review and approval for release of products.

What you will do::

• Serve as the Management Representative for the Argon Medical Athens facility.
• Quality Management System (QMS):
1. Maintain and improve the QMS in accordance with ISO 13485 and FDA 21 CFR Part 820.(Quality Management System Regulation QMSR) and MDSAP associated regulations
2. Develop and update quality policies, procedures, and manuals.
3. Monitor key performance indicators (KPIs) for quality effectiveness.
• Audits and Inspections:
1. Plan, conduct, and manage internal audits.
2. Lead external audits and regulatory inspections (e.g., FDA, Notified Bodies).
3. Ensure timely closure of audit findings and CAPAs.
• Regulatory Compliance:
1. Ensure compliance with CE marking, FDA clearance (e.g., 510(k)), and other global regulatory submissions.
2. Collaborate with Regulatory Affairs to identify and implement regulatory requirements.
• CAPA and Non-Conformance Management:
1. Investigate quality events, deviations, and complaints.
2. Lead root cause analysis and implement corrective and preventive actions (CAPA).
• Training and Mentorship:
1. Train staff on QMS procedures, regulatory requirements, and quality standards.
2. Foster a culture of quality and continuous improvement.
• Documentation and Record-Keeping:
1. Oversee document control processes.
2. Ensure proper maintenance of design history files, device master records, and quality records.
• Cross-Functional Collaboration:
1. Work closely with R&D, manufacturing, clinical, and regulatory teams.
2. Support product development and lifecycle management from a quality perspective.

• Team Leadership

1. Supervise QA staff including quality engineers, auditors, document control specialists, and technicians.
2. Provide clear direction, set performance expectations, and conduct regular performance reviews.
3. Foster a culture of accountability, collaboration, and continuous improvement.

• Staffing & Development

1. Recruit, onboard, and train new QA team members.
2. Identify skill gaps and provide coaching, mentoring, and development opportunities.
3. Ensure cross-training to maintain operational flexibility and coverage.

Skills for Success::

• Establishes develops, organizes, and monitors information and procedures to ensure high quality of work.
• Able to make sound decisions in difficult or ambiguous situations when time is critical.
• Approaches challenging tasks with a "can-do" attitude; effectively handle several problems or tasks at once.
• Fosters teamwork within on team and across organizational units; provides assistance, information, or other support to others, to build or maintain relationships with them
• Establishes structures and processes to plan Innovation: and manage the orderly implementation of change; can personally develop a new method or approach.