Job Description

The Quality Control Inspector is responsible for performing routine inspections of components, subassemblies, and finished products to ensure compliance with approved drawings, specifications, inspection plans, and regulatory requirements. This role supports product quality, safety, and effectiveness while maintaining compliance with current Good Manufacturing Practices (cGMP), FDA Quality System Regulations (21 CFR 820), and other applicable quality standards. This position will also assist the Document Control Coordinator in creating, reviewing, routing and controlling document changes per established procedures.

Essential Functions & Accountabilities:

• Perform routine and detailed inspections of incoming materials, in-process goods, and finished products.

• Conduct visual, dimensional, mechanical, and functional inspection using approved methods, tools, and equipment.

• Ensure components, subassemblies, and finished products comply with approved company drawings and specifications.

• Document inspection results to ensure full traceability.

• Identify, document, and report defects or nonconformances (NCMRs) and determine disposition of product (accept, reject, rework, return to vendor) in accordance with approved company procedures.

• Support site DCC with creation of COCs and COAs

• Assists Document Control Coordinator for controlled document changes and place them in Controlled floor locations
• Assists with upkeep of training records, Calibration records and with third party audits, supporting management with documentation as needed.
• Reviews and approves certification of conformance at incoming inspection location and scans them into MasterControl.
• Scans completed DHRs for electronic record retention.

• Perform other duties as assigned.

Qualifications

Knowledge, Skills and Abilities:

• Working knowledge of cGMP, FDA quality system regulations, and quality inspection practices in a regulated environment.
• Ability to interpret drawings, specifications, and inspection methods.
• Working knowledge of 21 CFR 820, ISO 13485, EU MDR, MDSAP, and other global standards
• Experience and ability in reading and interpreting engineering drawings.
• Proficiency using inspection tools and measuring equipment.
• Experience with electronic document management system.
• Related or similar Document control experience in highly regulated industrial setting. Dexterity and precision required to operate gauges and testing equipment.
• Working knowledge of Microsoft suite of products, including Excel, Word, and Outlook.
• Basic blueprint reading skills with GD&T knowledge and demonstrated proficiency with measurement/inspections.
• Ability to review and comprehend written instructions to include blueprints, specifications, and methods.
• Strong attention to detail and accuracy.

• Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).

• Strong organizational, troubleshooting, and problem-solving skills.