Quality Engineer II - Repair

Requisition
Title:
Quality Engineer II - Repair

Responsible for supporting the Quality Manager with all quality related support for the life cycle development of Class I, II and III medical devices, including new product development, product repair activities, and maintenance of released products.

• Review design drawings for tolerance, inspect-ability and quality of design issues.
• Work with suppliers to improve quality, and assist, where necessary, in supplier process validations.
• Assist in the training of QC Inspectors on inspection techniques and the use of new equipment.
• Participate in Internal and External quality audits as directed by the Quality Assurance Manager.
• Support Risk Management by leading or participating in cross-functional team pFMEAs and Risk Assessments.
• Support the AMI Engineering Change Management process by performing tasks as assigned.
• Lead or support the internal manufacturing First Article Inspection process, review First Article Inspection Reports and samples (internal and/or supplier).
• Lead or support equipment or process validation (IQ, OQ, PQ).
• Lead or support Metrology with design and development of inspection methods and gages.
• Create or review inspection method work instructions.
• Lead or support Metrology with Measurement System Analysis (Gage R&R) studies.
• Create Inspection Plans Supporting Receiving and In-Process Inspection.
• Investigate complaints as requested by the Complaints/Reliability team.
• Lead completion of Nonconformances (NCRs) as assigned: material disposition plans, evaluations, and action plans.
• Perform routine Nonconformance and process trending and lead periodic Quality review meetings with the management team.
• Lead or Support Continuous Improvement projects.
• Approves manufacturing and repair product process changes and assures the change management is controlled, adequate, and documented.
• Complete Root Cause Analysis Investigations and define Corrective/Preventive Action Plans (CAPAs).
• Perform Engineering Studies and Design of Experiments (DOE) as needed.
• Work with Manufacturing Engineers and Service Engineers in troubleshooting failures, repairs, and evaluating devices in the Repair and Production Departments.
• Determine the necessity of testing and initiate testing of assigned products by preparing test and inspection plans and identifying and obtaining required test fixtures and test/inspection instrumentation.
• Complete required complaint management activities, including review of investigation results for accuracy, recording investigation findings into the complaint management system, communication of findings and implications to applicable staff and management, and dispositioning devices associated with complaints.
• Other duties as assigned.

• 2 years of experience in a Quality Control or Quality Assurance position required, preferably in a medical device company.
• Bachelor of Science degree or greater in Engineering required (Mechanical, Electrical, or Biomedical preferred).

• Knowledge of testing equipment, statistical methods, and control plans.
• Manufacturing process knowledge. Technical knowledge in development methodologies including:
  Design Controls, GD&T, DOE, Process Verification and Validation.
• Knowledge of FDA, ISO
  13485 and CMDR Quality System requirements, ISO 14971 Risk Management standard to medical devices, EN60601, Medical device safety and EMC, and RoHs Directives preferred.
• Knowledge of Process Improvement tools (Lean – PDCA, and Six Sigma – DMAIC) and problem solving preferred.
• Working knowledge of risk assessments, PFMEAs, control plans and quality plans.
• Understanding of applicable medical device regulations for electrical safety and EMI/EMC preferred.
• Rudimentary technical knowledge in development, inspection methods, design for manufacturing, and corrections and corrective actions.
• Project management skills preferred.
• Strong communication skills and ability to communicate effectively with technical and non-technical staff.
• Knowledge of processes or equipment for assembly of electromechanical systems preferred.

• Proficiency in the use of PC and programs, particularly Excel, Word, Mini Tab or similar statistical analysis software, SAP or similar inventory software, Windchill or similar design lifecycle software, IQVIA Smartsolve or similar QMS software.
• Knowledge of measurement and other inspection equipment.
• Manufacturing and inspection process knowledge required.

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. Prefer working knowledge and application of Statistics.