Quality Assurance/Regulatory Affairs Manager

at TEMPO Employment Services in Presque Isle, Maine, United States

Job Description

Develop, implement, and maintain the quality management system to align with the organization’s strategic direction and ensure devices and products comply with customer, quality, regulatory, and statutory requirements.

• Ensure the Presque Isle facility complies with applicable quality and regulatory requirements, including ISO 9001, EN ISO 13485, EU MDD/MDR, MHLW Ordinance No. 169, and FDA/cGMP standards.
• Partner with senior management to set quality policies, procedures, goals, staffing, and budget.
• Lead Quality Assurance and Quality Control functions to support compliance and organizational goals.
• Develop, maintain, and improve the quality management system, including documentation, processes, and work instructions.
• Report quality management system performance, risks, and improvement needs to management and regulatory authorities as required.
• Review technical issues, recommend process improvements, and respond to changing business and market needs.
• Work across departments and with external providers to resolve complaints, nonconformances, and other quality issues.
• Oversee compliance activities for new products, validations, and the control of nonconforming product.
• Monitor applicable standards and regulations and promote awareness of customer and quality requirements throughout the organization.
• Investigate customer complaints, conduct root cause analysis, implement corrective and preventive actions, and prepare customer responses.
• Serve as the facility liaison on quality management matters and perform other duties as assigned.