1. Comply with applicable FDA regulations and ISO 13485 requirements.
2. Adhere to company Quality Management System (QMS).
3. Analyze problems and recommend changes.
4. 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.
5. Use gages and controlled components to verify functional fit.
6. Use standard measuring instruments and robotic arm for dimensional checks.
7. Conduct some in-process and outgoing inspection.
8. Test incoming goods, such as electronic devices and PCBs.
9. Report non-conformances, such as dimensional discrepancies, defects in materials and workmanship, and damage occurring in transit.
10. Initiate MRB actions and facilitate process through closure.
11. Take part in root cause analysis.
12. Support corrective and preventive actions.
13. Work with Supply Chain in returning nonconforming goods to suppliers. 
14. Develop and maintain receiving inspection files and records.
15. Document in-house inspection results.
16. Maintain records for inspection data and unplanned events.
17. Identify trends in non-conformances and other unplanned events.
18. Maintain calibration program.
19. Support FDA inspections, external and internal ISO audits.
20. Maintain a safe and healthful work environment.
21. Participate in training program(s).
22. Performs related duties as assigned.

• Superior interpersonal skills; ability to deliver the message of non-conforming material in a non-confrontational manner
• 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 non-conformances.
• Meticulous documentation and recordkeeping habits.
• Calibration system maintenance.
• Intermediate Computer skills: Microsoft Office Suite (including PowerPoint, Office, Outlook, Visio, Excel, Project)
• 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.

• Associate degree or equivalent training in quality assurance.
• 3–5 years in a quality assurance role in a regulated industry—medical device manufacturing preferred.

1. Sedentary physical activity requiring reaching, sifting, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing
2. Visual requirement is for close vision, distance vision, peripheral vision and ability to adjust focus
3. Ability to regularly lift/move up to 25 pounds, occasionally lift/move 50 pounds
4. 30% or more time is spent looking directly at a computer.
5. Associate is frequently required to stand, walk (or otherwise be mobile).

• Maintain a safe and healthful work environment.
• Ability and willingness to learn.

DISCLAIMER

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.