Job Summary

We are seeking a highly skilled and detail-oriented professional to lead our Quality Management System (QMS) initiatives. The ideal candidate will possess extensive expertise in quality assurance, regulatory compliance, and manufacturing standards, with a proven track record of implementing and maintaining effective quality systems. As the leader of our QMS team, you will oversee the development, implementation, and continuous improvement of quality protocols to ensure compliance with industry standards and legal requirements. Your role is pivotal in fostering a culture of quality excellence across all manufacturing processes, ensuring that products meet the highest standards of safety, efficacy, and regulatory adherence.

Duties

• Develop, implement, and maintain comprehensive Quality Management Systems aligned with ISO 13485 standards and other relevant regulations.
• Conduct regular quality audits to evaluate compliance with internal policies and external regulatory requirements such as FDA regulations and GMP standards.
• Lead root cause analysis and corrective action initiatives to address quality issues promptly and effectively.
• Collaborate with cross-functional teams—including manufacturing, engineering, and regulatory affairs—to ensure quality standards are integrated into all operational processes.
• Monitor key performance indicators related to quality control and assurance to drive data-driven decision-making.
• Ensure compliance with legal and regulatory standards applicable to manufacturing environments across various jurisdictions.

Qualifications

• Experience practicing in an industrial or manufacturing engineering role with a focus on quality management systems.
• Knowledge of ISO 13485 (medical devices) standards, and FDA compliance standards.
• Proven expertise in conducting quality audits
• Excellent analysis skills for root cause analysis, data interpretation, and process optimization.
• Strong project management skills with the ability to prioritize tasks in fast-paced manufacturing environments.
• Exceptional written and verbal communication skills for clear reporting, training delivery, and stakeholder engagement.
• Must be a US Person

Join us in advancing our commitment to excellence by ensuring our products meet rigorous quality standards through innovative management systems!

Pay: $28.00 - $30.00 per hour

Benefits:

• 401(k)
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement

Work Location: In person