Job Description

Job Description:

The Quality Engineering Manager is a proactive, critical thinker responsible for leading the Quality Management System (QMS) across four manufacturing sites. This role ensures compliance with FDA and ISO 9001 regulations, manages site quality teams, and champions a culture of quality and continuous improvement on the manufacturing floor.

Key Responsibilities:

• Lead and maintain the Quality Management System (QMS) across all four manufacturing facilities, ensuring standardization, compliance, and continuous improvement.
• Serve as the primary representative for FDA, ISO, and other regulatory audits and inspections.
• Supervise, develop, and coach site Quality Leaders and QC staff, fostering high-performance and accountability.
• Oversee day-to-day quality control operations, ensuring frontline inspections meet specifications and addressing issues in real-time.
• Evaluate and validate raw materials, with emphasis on radiation protection materials, to ensure they meet internal and regulatory standards.
• Manage medical device registration activities, including GUDID submissions and GTIN coordination with internal departments.
• Analyze and report on quality metrics, including supplier performance, nonconformances, and trends, and present findings to senior leadership.
• Lead internal audit and CAPA (Corrective and Preventive Action) processes to drive root cause resolution and systemic improvement.
• Monitor and escalate critical quality issues and risks to senior management with recommended actions.
• Collaborate with production leadership to resolve quality issues on the floor and implement preventive measures.
• Lead qualification and validation efforts for products and processes.
• Drive supplier quality improvement and corrective actions; conduct supplier audits as needed.
• Support New Product Development (NPD) initiatives, ensuring design controls and compliance requirements are met.
• Communicate quality and compliance issues effectively across all organizational levels, from operators to executives.
• Recommend and implement enhancements to quality systems and processes.

Qualifications:

• Bachelor’s degree in Engineering, Business Management, or related field (required).
• 5–7 years of progressive quality assurance experience in manufacturing, preferably in a regulated industry.
• Strong knowledge of ISO 9001; familiarity with ISO 13485 preferred but not required.
• Strong knowledge of QMS frameworks including FDA 21 CFR Part 820.
• Experience leading audits and maintaining compliance across multiple manufacturing sites.
• Hands-on experience with frontline quality control, root cause analysis, and resolution of in-process defects.
• Proven ability to manage and develop teams across functions and locations.
• Data-driven mindset with experience developing and analyzing quality metrics.
• Preferred certifications: Certified Quality Auditor (CQA), Regulatory Affairs Certification (RAC), Six Sigma or Lean certification.