QA Inspector

Hours : 1st Shift Mon-Fri

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POSITION SUMMARY :

The IQA Inspector role supports manufacturing quality assurance activities of Argentum Medical. This position tests and inspects products at various stages of production process and maintain quality and reliability of products.

Essential Functions (ACCOUNTABILITIES / RESPONSIBILITIES) :

• Perform required inspection and testing of incoming product according to quality control plan
• Perform first article inspection and testing for Engineering
• Perform in-process and pouch seal inspection according to quality control plan
• Perform first article label inspection for finished product
• Final inspection on Over label work order
• Provide assistance in the overall implementation and administration of Company policies and procedures
• Document and maintain accurate records of inspection and calibration results
• Communicate with appropriate Quality, Operations and Engineering personnel to ensure product and customer requirements are continually met
• Clearly document non-conformities and communicate issues to Quality and engineering personnel
• Assist with the Material Review Board process for the disposition of material, parts and finished product
• Control non-conforming material, parts and product in accordance with documented procedure
• Maintain QA Hold Area up to date
• Maintain Incoming Quality Inspection, SCAR, DHR records up to date
• Process owner for CAPA and SCAR process -Trending, tracking, ensuring deadline, Monitoring overall program
• Coordinate with Supplier for SCAR, Complaint or on open other investigation
• Assist with the development of inspection requirements and techniques
• Ensure calibration and maintenance is performed on inspection equipment
• Read and interpret inspection data from outside sources
• Participate in Quality audits to verify compliance with documented procedures and regulatory requirements
• Implement process controls by promoting and following all safety and quality system procedures as well as Company policies
• Conduct or assist with supplier auditing
• Conduct particulate counts in Environmentally Controlled Room in accordance with documented procedure
• Any other duties or responsibilities required or assigned by Director or Associate Director of Regulatory Affairs and Quality Assurance

Qualifications : Experience

Education

General Skills / Competencies / Specialized Knowledge

Not Required but Preferred :

TRAVEL REQUIREMENTS / WORK ENVIRONMENT and PHYSICAL DEMANDS :

Travel

Work Environment and Physical Demands