QA/QC Technician

Job Overview
We are seeking a highly motivated and detail-oriented QA/QC Manager to lead our quality assurance and quality control initiatives across manufacturing operations. In this pivotal role, you will ensure that all products meet the highest standards of safety, compliance, and quality, fostering continuous improvement within our quality systems. Your expertise will drive adherence to industry regulations, including ISO 13485, FDA regulations, HACCP, CGMP, and ISO 9001, while promoting a culture of excellence and precision. This is an exciting opportunity for a proactive leader passionate about maintaining rigorous quality standards and enhancing operational efficiency.

Duties

• Develop, implement, and maintain comprehensive quality management systems aligned with ISO 13485, FDA regulations, HACCP, CGMP, and ISO 9001 standards.
• Lead internal and external quality audits to verify compliance with regulatory requirements and company policies.
• Oversee all aspects of quality inspection and control throughout the manufacturing process to identify defects or deviations early.
• Coordinate with cross-functional teams to resolve quality issues promptly and effectively through root cause analysis and corrective actions.
• Manage documentation related to quality assurance activities, including inspection reports, audit findings, and compliance records.
• Conduct regular training sessions for staff on quality protocols, regulatory updates, and best practices in quality management.
• Drive continuous improvement initiatives by analyzing data trends and implementing process enhancements to elevate product quality.

Skills

• Extensive knowledge of ISO 13485 (medical device quality management), FDA regulations (21 CFR Part 820), HACCP principles, CGMP guidelines, and ISO 9001 standards.
• Proven experience in conducting comprehensive quality audits within manufacturing environments.
• Strong understanding of manufacturing processes coupled with expertise in quality control and inspection techniques.
• Excellent analysis skills to interpret data trends and identify areas for improvement.
• Project management capabilities to coordinate multiple initiatives simultaneously while maintaining attention to detail.
• Effective communication skills for training teams, reporting findings, and collaborating with regulatory bodies.
• Demonstrated leadership in developing and maintaining robust quality systems that support compliance and operational excellence. Join us as we uphold the highest standards of quality in our products! Your dedication will ensure safety, compliance, and customer satisfaction at every stage of production—making a meaningful impact on our organization’s success.

Job Type: Full-time

Pay: $43.00 - $55.00 per hour

Expected hours: 40 – 60 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person

Salary : $43 - $55