QMS Enginner
Core
Developing, implementing, and maintaining the Quality Management System (QMS) to ensure compliance with industry standards and regulatory requirements.
Role type
QMS Engineer
Builds
Quality Management Systems compliant with ISO 9001, AS9100, ISO 13485
Domain
Manufacturing / Electronics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS development and maintenance, internal and external audit leadership, CAPA process management, risk management (FMEA), quality documentation creation, statistical process control (SPC), root cause analysis (8D, 5 Whys), supplier quality management
Preferred skills
ASQ CQE or CQA certification, experience with AS9100 or ISO 13485
Technologies
ISO 9001, AS9100, ISO 13485, 8D, 5 Whys, FMEA
Responsibilities
Develop and maintain QMS per ISO standards, lead internal and external audits, manage CAPA processes, facilitate risk management activities, develop quality documentation, provide QMS training, monitor quality performance data, participate in design reviews and NPI, collaborate on cross-functional quality issues, support supplier quality audits
Seniority
Mid-level, hands-on IC