• Perform mechanical/functional/physical and first article inspection of incoming product from suppliers, including paperwork verification in conformance to established requirements or assist in other quality functions as needed.
• Perform in-process and final inspection of finished product which will include verification of components to engineering records and documentation requirements.
• Access and interpret engineering drawings, specifications, purchase orders, work orders etc. to determine quality status and support manufacturing.
• Prepares appropriate documentation and labels for quality and manufacturing/assembly process.
• Reviews manufacturing batch records against applicable quality requirements and document results of inspections.
• Identify and clearly communicate nonconformance’s to specified requirements to Management in timely manner.
• Organize QA inspection area. Support completed batch records scanning and records retention.
• Use Microsoft Office & other related software to accurately document and maintain associated paperwork and inspection results in a consistent and timely fashion.
• Provide QA floor support activities including participating in cost out activities, additional data collecting and maintaining Quality data storage.
• Identify and communicate continuous improvement opportunities for the quality program for internal and external customers.
• Perform other relevant duties as may be assigned by management.

Education and/or Work Experience Requirements:

• High School diploma or Two-year technical degree (ASME) or equivalent from an accredited technical institution is preferred.
• Machine shop experience in the quality discipline or a related field will be considered.
• Strong mechanical background, minimum 5-years’ experience.
• Familiar with medical devices, pharmaceutical, military or aerospace industry.
• Experience with ISO 9001, ISO 13485, 21CFR820 or equivalent QMS standards.
• Requires demonstrated use of mechanical inspection hand tools.
• Requires demonstrated use of basic Microsoft Office tools (Outlook, Excel, Word).
• Blueprint reading skills.
• Working knowledge of GD&T and familiarity with ASME BPE codes a plus.
• Knowledge of AQL Inspection plans.
• Team oriented with good organization skills.
• Good written and verbal communication skills.
• Must be able to remain in a stationary position
• Regularly required to sit, stand, use hands
• Occasionally move about inside office

Physical Requirements:

• Ability to work in a laboratory environment and exposure to hazardous materials
• Regularly required to stand, sit, walk, use hands and arms
• Lift/ or move up to 25 pounds