Position: Quality Supervisor – Night Shift (3PM-12AM)
DEPARTMENT: Quality Assurance
REPORTS TO: Sustaining Quality Manager
DIRECT REPORTS: Quality Technicians and Finished Goods Specialists
Overview:
The Night Shift Quality Supervisor is responsible for leading all quality activities during the night shift to ensure products meet customer, regulatory, and company quality requirements. This role provides direct supervision of all Quality Technicians and Inspectors, supports manufacturing operations, drives containment and corrective actions, and ensures compliance with ISO 13485, FDA regulations, and internal quality procedures.
The Night Shift Quality Supervisor serves as the primary quality authority during off-shift operations and works closely with Production, Engineering, Maintenance, and Manufacturing Engineering to resolve quality issues while minimizing production interruptions.
This is a hands on – roll-up your sleeves position.
Responsibilities:
· Leadership
o Supervise, coach, develop, and evaluate all Night Shift Quality Technicians and Inspectors.
o Establish daily priorities and assign inspection resources based on production schedules.
o Ensure adequate quality coverage across all manufacturing areas.
o Conduct shift meetings to communicate quality concerns, customer issues, and production priorities.
o Foster a culture of accountability, continuous improvement, and customer focus.
· Manufacturing Support
o Provide immediate quality support to molding, assembly, secondary operations, and packaging.
o Make disposition decisions on suspect products in accordance with established procedures.
o Lead containment activities for nonconforming product.
o Support production start-ups and first article inspections.
o Verify process adherence and compliance with approved work instructions
· Product Inspection
o Ensure in-process, first piece, last piece, and final inspections are completed accurately.
o Review inspection documentation for completeness and accuracy.
o Verify calibrated inspection equipment is used properly.
o Monitor inspection performance to ensure customer specifications are consistently met
· Nonconformance Management
o Initiate Nonconformance Reports (NCRs).
o Coordinate segregation and identification of nonconforming material.
o Support root cause investigations.
o Assist with implementation and verification of corrective actions.
o Escalate significant quality concerns to management when required
· ISO 13485 & Regulatory Compliance
o Maintain compliance with ISO 13485 and requirements.
o Verify Device History Records and quality documentation are complete.
o Support internal and external audits as required
· Continuous Improvement
o Identify recurring quality issues and recommend process improvements.
o Monitor scrap, rework, and defect trends.
o Assist in updating inspection methods and standardized work
· Communication
o Provide detailed shift reports and communicate any concerns to day shift management.
o Coordinate with Engineering and Manufacturing to resolve technical issues.
o Maintain professional communication with all departments.
Requirements
· Maintain a strong visible presence on the production floor.
· Make timely quality decisions that protect the customer.
· Reduce quality escapes.
· Improve response time to production issues.
· Develop a highly engaged and capable Quality Technician team.
· Promote continuous improvement throughout the organization.
Qualifications
· An associate or bachelor’s degree, or the equivalent in work experience, is required.
· Experience in manufacturing is preferred, with excellent problem-solving skills and the ability to find root cause regarding operational issues.
· Must have demonstrated teaching skills, with a desire and the ability to train others to understand and follow quality systems and procedures.
· Strong leadership skills and experience supervising others in a manufacturing environment desirable.
· Experience with ISO standards, GDP, Root Cause Analysis, Corrective Actions and measurement inspection systems preferred but not required.
· Experience with injection molding or plastics is preferred but not required.
Compensation: $75,000 - $90,000 depending on experience.