Start Time (AM/PM)      8 am

End Time (AM/PM)        5 pm

Job Responsibilities

• Supports manufacturing and testing operations adhering to Good Manufacturing Practices and Good Laboratory Practices to satisfy regulatory requirement for receiving and inspection.
• Performs all job duties in full accordance with the Client Global and Technical standards and complies with Client Quality System (QS) requirements.
• Ensures parts are compliant for all parts going to the manufacturing floor and any parts going directly to the customer.
• Completes tier 1 & tier 2 inspections to test inbound material that will be used to assemble complex medical devices:

Tier 1 inspections:

• Manual routine inspections utilizing hand tools such as calipers, gauges (ring, pin, thread, height), rulers as well as visual inspections to test inbound material that will be used to assemble complex medical devices.
• May operate upper level instrumentation.

Tier 2 inspections:

• Operate advanced upper level instrumentation: 3D/2D Digital Measuring projector and/or Optical Testing and Visualization Instruments (e.g. Optical Gaging Product (OGP), Keyence IM, etc.)
• Performs inspection on printed material (e.g. Primary and Secondary labeling; manuals; print inserts; CD’s; etc.).
• Accepts and rejects supplier lots based on inspection results. The information gathered is used by others to make both critical and strategic decisions.
• Documents the non-conformance or suspected non-conformance to standards (i.e. manufacturing documentation, material/ component specifications, operating procedures, and domestic/ international standards) through the identification of unsuccessful audits, the completion of required paperwork, system transactions, and affixing his or her mark (i.e. stamp, sign-off or signature).
• Reviews applicable sampling plans and control plans to verify product and services conform to quality and other engineering and Quality Assurance requirements.
• Interprets drawings
• Performs comparison between supplier and internal measurement/inspection methods.
• Provides alternative inspection methods.
• Uses technical knowledge to acquire, analyze, and interpret data. Applies information and methods for problem solving.
• Assignments require considerable judgment, initiative, creativity and leadership in troubleshooting, suggesting alternatives, and making recommendations for continuous quality improvement.
• Performs set-up, testing, and troubleshoots all area-specific equipment, materials, systems, and/or product.
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, ISO or other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Adheres to all environmental, health and safety SOP’s, equipment, policies and procedures, including any department specific requirements.

Minimum requirements

• High School Diploma or GED required
• 2-5 years’ experience
• Previous experience in Quality performing inspection.
• Experience with measurement equipment, hand tools, gages, pressure and force gage testing
• Training in blueprint reading and experience with inspection sampling techniques
• Knowledge of FDA, GMP, ISO 13485.
• Good communication and computer skills, including Microsoft Word and Excel."