We are seeking a detail-oriented and highly motivated Quality Control Inspector to join our team. In this role, you will be responsible for performing a variety of inspection and testing activities to ensure components, materials, and finished products meet specified quality standards. Working within the framework of our ISO 13485 and 21 CFR 820-compliant Quality Management System (QMS), the Quality Control Inspector will follow defined Acceptable Quality Limits (AQLs), inspection plans, and standard operating procedures to uphold product quality and regulatory compliance.

QUALIFICATIONS:

• High school diploma or equivalent required; technical training or associate degree in a related field preferred.
• Minimum of [X] years of experience in a quality control or inspection role, preferably in a regulated manufacturing environment (medical device or pharmaceutical experience a plus).
• Working knowledge of ISO 13485 and 21 CFR 820 standards.
• Proficient with common inspection tools and equipment.
• Strong attention to detail and analytical skills.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a team-oriented environment.

• Conduct incoming material inspections in accordance with component quality inspection plans and documented work instructions.
• Perform first article inspections and in-process inspections on subassemblies and finished products.
• Utilize a wide range of inspection tools and equipment, including but not limited to digital height gauges, calipers, optical comparators, vision systems, durometers, and visual inspection tools.
• Apply appropriate AQL sampling plans and determine pass/fail criteria based on inspection results.
• Accurately label and disposition inspected materials in accordance with established procedures.
• Ensure proper documentation in line with Good Documentation Practices (GDP), maintaining complete and accurate records in the quality assurance database.
• Collaborate with production operators and supervisors to reinforce quality policies and procedures; assist in the training of personnel on new quality initiatives as needed.
• Evaluate the acceptability of reworked products through physical testing and inspection.
• Support inspection efforts on the manufacturing floor and packing lines as necessary.
• Perform sampling and testing of incoming materials, components, and equipment to ensure compliance with internal specifications.
• Determine appropriate inspection methods, sequences, and procedures for new or complex components.
• Apply identification labels to accepted or rejected materials based on inspection results.