Quality Technician

Job Details:

• Part-Time

• Reports To: Quality Manager

• FLSA Status: Non-Exempt

• On-site position
  

Job Responsibilities:

• Maintain and control packaging artwork and perform incoming quality inspections on packaging-related materials

• Ensure incoming materials meet predetermined specifications; approve or reject materials based on findings

• Properly status label incoming materials and quarantine suspect materials

• Review Device History Records (DHR) at the completion of each production run

• Perform post-packaging quality audits per established SOPs and release product to distribution based on audit results

• Review rework activities and documentation to ensure compliance with applicable SOPs

• Provide GMP and Quality training to Production Associates and ensure adherence to SOPs and regulatory requirements

• Assist with Internal Audits and CAPA activities

• Assist with packaging artwork review and approval processes

• Support Document Control activities for SOPs and Work Instructions

• Monitor Production activities to support process improvements and ensure compliance

• Comply with all quality directives, SOPs, cGMP, and health and safety requirements
  

Job Qualifications:

• High School diploma required; some college education preferred

• Must be able to read, write, and communicate effectively in English

• Prior Quality Control/Quality Assurance experience in the medical device field required

• Knowledge of GMP, cGMP, and quality systems preferred

• Strong attention to detail and organizational skills

• Ability to work independently and follow established procedures

• Comfortable working in a regulated manufacturing environment