Product Complaint Investigator II-Defined Term Employee (12 Months)
Core
Execute product complaint investigations involving decontamination, analysis, testing, and technical documentation for medical devices to ensure regulatory compliance and high-quality outcomes.
Role type
Product Complaint Investigator (Quality/Laboratory)
Builds
Technical documentation (SEFs), test reports, and compliance records for medical device product lines.
Domain
Medical Devices / Quality Assurance / Laboratory Testing
Required skills
Product complaint investigation, laboratory testing, technical documentation, measurement tools usage, regulatory compliance, problem-solving, cross-functional collaboration, technical writing, training junior staff, laboratory operations management
Preferred skills
Medical device investigation, Safety Evaluation Form preparation, new product development support, continuous improvement methodologies (Lean, Six Sigma), laboratory equipment management, cross-functional technical communication
Technologies
Calipers, micrometers, digital multimeters (DMMs), GCIBS, SEFs
Responsibilities
Perform decontamination, analysis, testing, and documentation of product complaints; execute investigations for moderate to high complexity products; prepare Safety Evaluation Forms (SEFs) with guidance; conduct product analysis using measurement tools; support simple New Product Development (NPD) activities; maintain compliance with quality systems and regulations; contribute to updates of work instructions and SOPs; participate in cross-functional meetings and escalate out-of-spec findings; support continuous improvement initiatives; train and support junior technicians; manage laboratory operational tasks like supply tracking and equipment ownership.
Seniority
Mid-level, hands-on IC