Job Description

JOB TITLE: QUALITY CONTROL SUPERVISOR

CLASSIFICATION: NON-EXEMPT – HOURLY

Reports to Operations Manager

JOB FUNCTION(S):

Responsible for overseeing daily quality control (QC) operations, ensuring that medical device products comply with FDA, ISO 13485, and GMP standards . This role supervises QC technicians, coordinates inspections, and supports continuous improvement initiatives to maintain high product quality.

EDUCATIONAL & PROFESSIONAL REQUIREMENTS:

• Minimum requirement: two (2) year degree in engineering or a like science and equivalent experience as a quality professional in a manufacturing setting; preferably medical device
  • Prior experience with plastics/ injection molding
    • Familiarity with and ability to interpret regulatory requirements and directives pertaining to medical devices
    • Understanding of FDA and ISO criteria
    • Excellent written and verbal communication skills
    • Proficiency with use of inspection tools and methods
    • Experience using MS Excel a plus
    • Experience using medical device labeling software/printers a plus
    • Experience using ERP software a plus

RESPONSIBILITIES:

• • • • Serve as a functional lead of the Quality Control department.
      • Train QC staff in inspection procedures and techniques.
      • Oversee incoming, in-process, and final inspections of raw materials, components, and finished products.
      • Ensure compliance with FDA 21 CFR Part 820, FDA 21 CFR Part 830, ISO 13485, and Good Manufacturing Practices (GMP) .
      • Review printed medical device labels.
      • Coordinate calibration of monitoring and measuring equipment in accordance with the calibration schedule.
      • Maintain inspection records, test reports, and quality documentation in compliance with regulatory standards.
      • Collaborate with Engineering and Production teams to identify quality issues and process inefficiencies , recommending corrective actions to improve inspection methods and manufacturing process controls.
      • Support Quality Assurance in performing non-conformance (NC) investigations and corrective/preventive action (CAPA) processes including root cause analysis .
      • Assist Quality Assurance with collection and analysis of QC data for Management Review.
      • Assist with other QC Department functions as required

        OTHER DUTIES:

    • Follow established safety procedures—Ref. Hobbs Hazard Communication & Lock/Out Tag Out Program policies
    • Attend seminars and workshops relevant to job responsibilities
    • Participate in Company meetings and functions, as requested in other departments when called upon to do so
    • Complete other duties as required or requested

      PHYSICAL REQUIREMENTS:

    • Sitting for long periods of time
    • Standing for long periods of time
    • Bend, squat, reach
    • Eye strain

Job Tags

Similar Jobs