Quality Assurance Specialist Job Summary:

MFI is seeking a detail-oriented and experienced Quality Assurance Specialist to join our team in the manufacturing of endoscopes, ensuring compliance with

ISO 13485

standards. The successful candidate will uphold quality standards, support regulatory requirements, and contribute to continuous quality improvement in our production processes.

Key Responsibilities:

• Implement and maintain

ISO 13485

quality management system (QMS) specific to medical device and endoscope manufacturing.

• Conduct internal audits and facilitate external audits to ensure ongoing compliance.
• Review and approve validation protocols, manufacturing processes, and inspection procedures.
• Perform supplier quality assessments and oversee incoming material inspections.
• Collaborate with design and manufacturing teams to address quality issues and implement corrective and preventive actions (CAPA).
• Monitor production processes for conformance to quality standards and specifications.
• Ensure proper documentation and recordkeeping for traceability and regulatory requirements.
• Support risk management activities and ensure risk assessments are up-to-date.
• Conduct training sessions on quality policies, procedures, and standards for staff.
• Leading equipment enrollment includes IQ, OQ, PQ, activities.
• Plan, execute, and document calibration of measuring and test equipment used in manufacturing and quality assurance processes, ensuring accuracy and traceability.
• Maintain calibration schedules for tools, gauges, and instruments in accordance with industry standards and regulatory requirements.

Ensure calibration records are properly maintained and readily available for audits and inspections. Work closely with equipment owners and external calibration service providers to ensure timely and complian

Pay:

$57,000.00

• $93,000.

00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off People with a criminal record are encouraged to apply

Experience:

Compliance:

3 years (Required)

Documentation:

3 years (Required) Quality assurance: 3 years (Required)

Work Location:

In person