General Accountabilities:

Inspection of incoming parts and outgoing devices for FDA regulated/ISO 13485 equipment.

Specific Accountabilities:

• Comply with applicable FDA regulations and ISO 13485 requirements.
• Adhere to company Quality Management System (QMS).
• Analyze problems and recommend changes.
• Verify that documents required of suppliers, such as certificates of conformance and first article inspection results, are provided for incoming goods, which include materials, parts, assemblies, machines, accessories, electronic devices, PCBs, and fabricated metal parts.
• Use gages and controlled components to verify functional fit.
• Use standard measuring instruments and robotic arm for dimensional checks.
• Conduct some in-process and outgoing inspection.
• Test incoming goods, such as electronic devices and PCBs.
• Report nonconformances, such as dimensional discrepancies, defects in materials and workmanship, and damage occurring in transit.
• Initiate MRB actions and facilitate process through closure.
• Take part in root cause analysis. 
• Support corrective and preventive actions.
• Work with Supply Chain in returning nonconforming goods to suppliers. 
• Develop and maintain receiving inspection files and records.
• Document in-house inspection results.
• Maintain records for inspection data and unplanned events.
• Identify trends in nonconformances and other unplanned events.
• Maintain calibration program.
• Support FDA inspections, external and internal ISO audits.
• Maintain a safe and healthful work environment.
• Participate in training program.

• Associate degree or equivalent training in quality assurance.
• At least three years' experience:
  • in a regulated industry in a quality role
  • in an ISO 13485 environment in a quality role
  • inspecting incoming machined parts and/or welded sub-assemblies
  • conducting root cause analysis and corrective/preventive actions
  • maintaining inspection and non-conformance records.

•  Superior interpersonal skills.
• Articulate verbal and written communication.
• Well-developed organizational and planning skills.
• Collaboration and consensus building in a team environment.
• Self-motivated—works independently with little supervision.
• Analytical and resourceful problem solving.
• Isolation of key issues from complex information. 
• Identification of patterns and trends in unplanned events and nonconformances.
• Meticulous documentation and recordkeeping habits.
• Calibration system maintenance.
• Intermediate computer skills:  Outlook, Word, Excel, Visio, database software, ERP.

• Functional understanding of the ISO 13485 International Standard.
• Practical knowledge of the FDA Code of Federal Regulations (CFR), Title 21, Part 820.
• QMS requirements, including nonconformance reporting (NCR), corrective and preventive action (CAPA), Material Review Board (MRB), and Root Cause Analysis (RCA).
• Incoming, in-process, and outgoing inspection techniques.
• Use of gages and standard measuring instruments.
• Familiar with current good manufacturing practices (cGMP).
• Understanding of common manufacturing processes.
• Knowledge of first article inspection (FAI) and certificates of conformance (CofC).
• Support of FDA inspections; external and internal ISO audits.

•  Maintain a safe and healthful work environment.
• Spend most of the time standing and sitting.
• Lift/carry 50 lbs.
• Ability and willingness to learn.