Supervisor, Quality Operations (Onsite - Acton, MA)
Core
Hands-on Quality Supervisor/Lead managing a team of Quality Technicians to ensure manufacturing products meet quality and regulatory standards.
Role type
Senior IC Quality Supervisor
Builds
Medical device manufacturing products
Domain
Medical Devices / Quality Assurance
Required skills
Team leadership, regulatory compliance (FDA 21 CFR 820, ISO 13485), inspection and testing procedures, nonconformance investigation, continuous improvement, data trending, process controls, equipment troubleshooting, documentation review
Preferred skills
Lean Six Sigma, SPC, ASQ methodologies, engineering/technical/scientific background, conflict resolution, technical writing, Microsoft software proficiency
Technologies
Microsoft software
Responsibilities
Hire, manage, and mentor direct reports; schedule work to achieve business goals; establish and track daily team metrics; perform complex tasks to ensure compliance with quality standards; collaborate with Quality Engineers on inspection/test procedures and equipment troubleshooting; develop standards and recommend procedural changes; review DHR documentation including inspection records and non-conformances; manage continuous improvement projects; approve/sign-off work of Quality Technicians
Seniority
Senior, hands-on IC
