What are the responsibilities and job description for the Quality Engineer position at Route 92 Medical Inc?
Job Description
Job Description
PURPOSE OF JOB :
This position will support Route 92 Medical's efforts to sustain a best practice Quality System by ensuring compliance to regulatory requirements (13485 : 2016, MDSAP, EU MDR 2017 / 745) as well as ensuring products meet all applicable internal and external requirements and specifications.
MAJOR DUTIES AND RESPONSIBILITIES :
- Identify, investigate, and disposition nonconforming material requests (NCMRs) in collaboration with Quality Control team and Operations.
- Identify, investigate, and implement corrective and preventive actions (CAPAs).
- Product decontamination and investigation of complaints.
- Environmental monitoring, Bioburden, and LAL monitoring.
- Calibration, maintenance, qualification where required.
- Support all other quality functions as requested by management.
- Act as lead or supporting auditor for Internal or Supplier Audits.
- Support relevant areas in external audits.
- Identify and implement Quality Management System improvements.
REQUIRED EDUCATION :
EXPERIENCE :
