Senior Quality Engineer - 18 Month Defined Term
Core
Senior Quality Engineer supporting a medical device acquisition, ensuring compliance with regulatory requirements and driving quality leadership in manufacturing operations.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Medical device production operations and quality management systems
Domain
Medical Devices / Healthcare
Required skills
Quality Management Systems (QMS), ISO 13485, regulatory compliance, root cause analysis, risk assessment, validation data review, nonconforming product disposition
Preferred skills
Audit experience, cross-functional collaboration, continuous improvement
Technologies
ISO 13485, QMSR
Responsibilities
Serve as Quality representative and subject matter expert for manufacturing and quality systems; Collaborate cross-functionally to resolve quality issues; Interpret technical drawings and procedures for compliance; Lead quality investigations and failure analyses; Review validation and test data for compliance; Support internal and external audits.
Seniority
Senior, hands-on IC