Partner with cross-functional teams to identify product risks, investigate potential failure modes, and implement effective risk control measures.
Ensure compliance with ISO 13485, FDA regulations, customer requirements, and applicable quality standards.
Develop, review, and maintain quality procedures, SOPs, and documentation to support product development and Quality Management System (QMS) requirements.
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Assist engineer in reviewing inspection & test plan, inspection checklist & documentation, QC report, etc.
Attending quality meetings and technical meetings.
Provide necessary technical input/advice/recommendation on construction issues such as design changes, non-conformance, deviation, sequence of work, subsurface conditions, etc.
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Performs and documents initial reportability decisions on complaints in accordance with regulations (US FDA) and international regulations (MEDDEV Vigilance, Health Canada, and others as applicable) and company procedures; Elevate complaints that require additional review for regulatory reporting.
Verify that the correct number of complaints have been opened to address all of the issues identified in the complaint description. If required, generate additional complaint records to document all of the issues listed in the complaint description.
Ensure that all complaints requiring customer responses are properly addressed, as assigned; drafts and documents the response in the complaint file.
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Test performance characterization includes test coverage, programming/calibration functions, automation, repeatability, reliability, safety, ergonomics, and supportability.
BS degrees in Electrical Engineering or related fields with 2-5 years working experience.