Quality Manager, Medical Devices

Overview
We are seeking a dedicated and detail-oriented Quality Manager to oversee and manage all aspects of the QMS to ensure compliance with FDA, ISO, and other global regulatory standards.

The ideal candidate will have a strong background in quality management, familiarity with FDA regulations, and experience in implementing effective quality systems. This role is crucial in maintaining the integrity of our products and ensuring customer satisfaction through rigorous quality control measures.

Duties

• Develop, implement, and maintain quality management systems to ensure compliance with FDA regulations and industry standards.
• Approve QMS-related documents, including procedures, audit reports, and CAPA plans.
• Lead internal audits, regulatory inspections, and external supplier audits.
• Provide recommendations for corrective and preventive actions based on quality performance data
• Train staff on quality assurance protocols and best practices to foster a culture of quality within the organization.
• Prepare detailed reports on quality metrics and present findings to senior management.

Skills

• Regulatory Expertise: knowledge of FDA 21 CFR Part 820, ISO 13485:2016.
• Analytical Skills: Ability to evaluate quality data, perform root cause analyses, and implement effective corrective actions.
• Communication Skills: Proficient in presenting QMS performance and recommendations to executive management and external auditors.
• Leadership: Demonstrated ability to lead cross-functional teams and foster a culture of quality and compliance.
• Problem-Solving: Strong analytical skills for root cause analysis, CAPA implementation, and addressing quality concerns.
• Attention to Detail: Thorough in ensuring QMS compliance and accuracy in documentation.
• Project Management: Ability to manage multiple quality initiatives and deadlines simultaneously.
• Technical Skills: Experience with quality management software and document control systems.

Qualifications:

• Education: Bachelor’s degree in Quality Management, Engineering, or a related field (advanced degree or certifications preferred, e.g., CQE, CQA).
• Experience: Minimum of 3 years of quality management experience in the medical device industry with specific experience in nuclear medicine preferred.
• Certifications: ISO 13485 Specialist/QMR/Lead Auditor, Six Sigma, or other relevant certifications are a plus.

Responsibilities:

• Quality Management System (QMS) Oversight
• Develop, implement, and maintain the QMS in compliance with FDA, ISO, CE Marking, and other relevant standards.
• Ensure QMS documentation is current, accurate, and audit-ready.
• Conduct internal and external audits to assess QMS effectiveness and drive improvements.
• Serve as the primary liaison during external audits by regulatory bodies and certification organizations.
• Regulatory Compliance
• Monitor and implement changes to regulatory standards to maintain compliance.
• Lead preparations for regulatory inspections and audits, managing responses and corrective actions.
• Ensure product compliance with FDA regulations throughout distribution lifecycle.
• Management Reporting
• Prepare and present QMS performance reports, including metrics on non-conformance, CAPAs,
• and audit results, to executive management.
• Lead management review meetings to evaluate the suitability, adequacy, and effectiveness of the
• QMS.
• Document Control and Training
• Oversee document control processes to ensure proper management and compliance.
• Develop and implement training programs to promote quality standards and regulatory compliance.
• Supplier Quality Management
• Establish supplier qualification and monitoring programs to ensure compliance.
• Conduct supplier audits and address non-conformances or deviations as needed.
• Continuous Improvement
• Drive continuous improvement initiatives to enhance QMS efficiency and effectiveness.
• Promote a quality-driven culture throughout the organization.
• Post-Market Surveillance and Complaint Management
• Oversee post-market surveillance activities, analyzing product performance and safety data.
• Manage complaint investigations, implement CAPAs, and address post-market trends to ensure product safety and efficacy.

This position offers an opportunity for growth within a dynamic team focused on delivering high-quality products and services. If you are passionate about quality assurance and have the skills necessary to excel in this role, we encourage you to apply.

Job Types: Part-time, Contract

Pay: $60,000.00 - $75,000.00 per year

Benefits:

• Flexible schedule
• Paid time off

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: In person

Salary : $60,000 - $75,000