Supervisor Quality Assurance
Core
Lead a team of quality inspectors and technicians to oversee receiving, in-process, and final inspections, tool qualifications, and first article inspections for medical devices.
Role type
First-line supervisory quality assurance manager
Builds
Quality control processes and regulatory compliance for medical device production
Domain
Medical devices / Vascular / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
team leadership, quality systems auditing, regulatory compliance (FDA), risk assessment, vendor liaison, process monitoring, staff development, operational implementation
Preferred skills
SAP, ASQ certification, Six Sigma, Lean Manufacturing
Technologies
SAP
Responsibilities
Provide day-to-day leadership, coaching, and development for a team of quality inspectors and technicians; Assign work, monitor performance, and support employee development; Ensure staffing and inspection coverage meet production requirements; Assure timely inspections that support materials, product releases and in-process inspections; Maintain staff and equipment to assure appropriate technical capabilities; Monitor inspection procedures for effectiveness; Monitor compliance to appropriate regulatory standards; Facilitate audits and regulatory inspections; Liaise with external vendors, contractors or suppliers to ensure that their products or services meet the organization's quality standards.
Seniority
First-line supervisor, hands-on management
