Argon Medical Devices, Inc.
Manager, Quality Operations & Compliance
Argon Medical Devices, Inc., Athens, Texas, United States, 75751
Overview
Manager, Quality Operations & Compliance. 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), regulatory requirements related to MDSAP, and other global standards. 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. 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):
Maintain and improve the QMS in accordance with ISO 13485 and FDA 21 CFR Part 820 (Quality Management System Regulation QMSR) and MDSAP related regulations.
Develop and update quality policies, procedures, and manuals.
Monitor key performance indicators (KPIs) for quality effectiveness.
Audits and Inspections:
Plan, conduct, and manage internal audits.
Lead external audits and regulatory inspections (e.g., FDA, Notified Bodies).
Ensure timely closure of audit findings and CAPAs.
Regulatory Compliance:
Ensure compliance with CE marking, FDA clearance (e.g., 510(k)), and other global regulatory submissions.
Collaborate with Regulatory Affairs to identify and implement regulatory requirements.
CAPA and Non-Conformance Management:
Investigate quality events, deviations, and complaints.
Lead root cause analysis and implement corrective and preventive actions (CAPA).
Training and Mentorship:
Train staff on QMS procedures, regulatory requirements, and quality standards.
Foster a culture of quality and continuous improvement.
Documentation and Record-Keeping:
Oversee document control processes.
Ensure proper maintenance of design history files, device master records, and quality records.
Cross-Functional Collaboration:
Work closely with R&D, manufacturing, clinical, and regulatory teams.
Support product development and lifecycle management from a quality perspective.
Team Leadership:
Supervise QA staff including quality engineers, auditors, document control specialists, and technicians.
Provide clear direction, set performance expectations, and conduct regular performance reviews.
Foster a culture of accountability, collaboration, and continuous improvement.
Staffing & Development:
Recruit, onboard, and train new QA team members.
Identify skill gaps and provide coaching, mentoring, and development opportunities.
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 handles several problems or tasks at once.
Fosters teamwork within one team and across organizational units; provides assistance to others to build or maintain relationships.
Establishes structures and processes to plan and manage change; can develop a new method or approach.
Seniority level
Not Applicable
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Medical Equipment Manufacturing
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What You Will Do
Serve as the Management Representative for the Argon Medical Athens facility.
Quality Management System (QMS):
Maintain and improve the QMS in accordance with ISO 13485 and FDA 21 CFR Part 820 (Quality Management System Regulation QMSR) and MDSAP related regulations.
Develop and update quality policies, procedures, and manuals.
Monitor key performance indicators (KPIs) for quality effectiveness.
Audits and Inspections:
Plan, conduct, and manage internal audits.
Lead external audits and regulatory inspections (e.g., FDA, Notified Bodies).
Ensure timely closure of audit findings and CAPAs.
Regulatory Compliance:
Ensure compliance with CE marking, FDA clearance (e.g., 510(k)), and other global regulatory submissions.
Collaborate with Regulatory Affairs to identify and implement regulatory requirements.
CAPA and Non-Conformance Management:
Investigate quality events, deviations, and complaints.
Lead root cause analysis and implement corrective and preventive actions (CAPA).
Training and Mentorship:
Train staff on QMS procedures, regulatory requirements, and quality standards.
Foster a culture of quality and continuous improvement.
Documentation and Record-Keeping:
Oversee document control processes.
Ensure proper maintenance of design history files, device master records, and quality records.
Cross-Functional Collaboration:
Work closely with R&D, manufacturing, clinical, and regulatory teams.
Support product development and lifecycle management from a quality perspective.
Team Leadership:
Supervise QA staff including quality engineers, auditors, document control specialists, and technicians.
Provide clear direction, set performance expectations, and conduct regular performance reviews.
Foster a culture of accountability, collaboration, and continuous improvement.
Staffing & Development:
Recruit, onboard, and train new QA team members.
Identify skill gaps and provide coaching, mentoring, and development opportunities.
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 handles several problems or tasks at once.
Fosters teamwork within one team and across organizational units; provides assistance to others to build or maintain relationships.
Establishes structures and processes to plan and manage change; can develop a new method or approach.
Seniority level
Not Applicable
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Argon Medical Devices, Inc. by 2x
Sign in to set job alerts for “Quality Operations Manager” roles.
#J-18808-Ljbffr