Manager, Quality Assurance (Onsite)
Core
Lead quality assurance activities to ensure product quality, process performance, audit readiness, and continuous improvement across site operations.
Role type
Manager, Quality Assurance
Builds
Quality systems, audit readiness, and compliance frameworks for medical device manufacturing
Domain
Medical device manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Team leadership, quality system management, corrective and preventive actions, change management, product and process validation, audit management, trend analysis, supplier quality support, strategic quality planning
Preferred skills
Quality management in medical device/pharma/biotech/automotive, CQE/CMQ/OE/Six Sigma certifications, knowledge of 21 CFR Part 820 and ISO 13485, FMEA, statistical process control, root cause analysis, mistake-proofing
Technologies
21 CFR Part 820, ISO 13485, FMEA, statistical process control, root cause analysis, mistake-proofing
Responsibilities
Lead and develop a team of quality professionals, partner with manufacturing teams to meet quality requirements, oversee quality system activities including investigations and validation, manage regulatory and internal audits, develop and report quality metrics, lead communications regarding product holds and field actions, implement training programs, support supplier quality and continuous improvement initiatives
Seniority
Manager, hands-on leadership
