Sr. Associate Quality Systems Specialist
Core
Senior Quality Systems Specialist ensuring compliance with medical device regulations and international quality standards by managing the Quality Management System (QMS), processing customer complaints, and supporting audits.
Role type
Senior IC Quality Systems Specialist (Medical Device/Pharma)
Builds
Quality Management System (QMS) compliance and operational integrity
Domain
Medical Device / Pharmaceutical / Regulated Healthcare
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS), electronic quality systems (eQMS), customer complaint processing, CAPA processes, document control, audit support, root cause analysis, data analysis, supplier quality documentation
Preferred skills
ISO 13485:2016, FDA regulations (21 CFR Parts 803, 806, 820, 210, 211), ISO 14971, ISO 10993, MasterControl, Jira, JDE, OneTrac, SailPoint, Adobe, statistical software (Minitab), technical writing, Mandarin language proficiency
Technologies
eQMS, MasterControl, Jira, JDE, OneTrac, SailPoint, Adobe, Minitab, Microsoft Office
Responsibilities
Maintain and process quality records within eQMS (complaints, CAPAs, deviations, change controls), receive and process global customer complaints, administer document control activities, support internal and regulatory audits, compile evidence for investigations and contribute to CAPA activities, maintain quality metrics and dashboards, assist with supplier quality documentation review and SCAR tracking
Seniority
Senior, hands-on IC