Engineering Manager

Job Responsibilities:

• Oversee site-wide quality engineering and validation, ensuring compliance with regulations and standards.
• Manage process monitoring, validation plans, and design transfers to support new product development.
• Lead root cause investigations for OOS, deviations, and customer complaints.
• Approve validation and technical reports, ensuring robust quality controls.
• Collaborate with cross-functional teams to drive CAPA initiatives and process improvements.
• Ensure product specifications align with site capabilities and customer requirements.
• Maintain audit readiness and participate in inspections and customer meetings.
• Lead and develop the Quality Engineering (QE) team, ensuring performance and effectiveness.
• Align department goals with site and corporate strategies.
• Manage staffing, training, career development, and succession planning.
• Oversee department budget and resource allocation.
• Establish and track KPIs to measure department and shop floor performance.
• Compile and analyze quality metrics to identify trends and improvement areas.
• Use data-driven insights to enhance product quality and process efficiency.

Qualifications:

• Bachelor’s degree in Engineering, Material Science, Data Analytics, Statistics, or a related technical field (or equivalent work experience).
• 5+ years of experience in the Medical Device or Pharmaceutical Industry 
• 3+ years of supervisory experience, including team leadership, coaching, and resource management.