Quality Control Specialist

The Quality Control Specialist is responsible for supporting product quality and regulatory compliance through incoming inspection, document control administration, training record management, and calibration program coordination. This role ensures that materials meet established specifications and that quality system documentation and records are maintained in accordance with company procedures and applicable regulatory requirements. The position plays a key role in maintaining the integrity and effectiveness of the Quality Management System (QMS).

• Perform incoming inspection of raw materials, components, and subassemblies against approved specifications, drawings, and acceptance criteria
• Ensure traceability of inspected materials and maintain proper identification status
• Review and approve supplier Certificates of Conformance (CoC), test reports, and supporting documentation
• Document inspection results accurately and maintain traceable quality records
• Identify, document, and elevate nonconforming materials per established procedures
• Support supplier quality activities by assisting with corrective actions and follow‑ups as needed
• Maintain and control quality documents including SOPs, work instructions, forms, and records
• Ensure documents are reviewed, approved, issued, revised, and archived in compliance with document control procedures
• Manage document change requests and ensure proper version control
• Support training documentation and ensure employees have access to current procedures
• Monitor training completion status and elevate overdue training as necessary
• Support onboarding training documentation for new employees and assist with periodic review of training matrices to ensure role‑based training needs are met
• Maintain the calibration program for inspection, measurement, and test equipment, including scheduling, coordination with approved service providers, and ensuring proper labeling and status identification
• Maintain calibration records and certificates, ensure timely removal of out‑of‑calibration equipment, and support impact assessments when required
• Assist with internal and external audits by preparing and retrieving documentation
• Support compliance with FDA Quality System Regulations (QSR) and applicable ISO standards
• Participate in internal audits, inspections, and regulatory readiness activities
• Assist with CAPAs, deviations, and quality investigations related to inspection or documentation
• Maintain accurate records in electronic quality management systems (eQMS)
• Other duties as assigned

• Associate degree or higher in Engineering Technology, Life Sciences, Quality, Manufacturing, or a related field
• Equivalent combination of education and experience may be considered

• 1‑2 years of experience in quality inspection and/or document control in a regulated industry
• Experience in medical devices, pharmaceuticals, biotechnology, or related manufacturing environments preferred
• Strong attention to detail and documentation accuracy
• Ability to read and interpret technical drawings, specifications, and procedures
• Working knowledge of inspection tools and measurement techniques
• Understanding of quality systems and regulatory documentation requirements
• Proficiency with Microsoft Office and document management systems
• Strong organizational, communication, and time‑management skills
• Ability to work independently and collaboratively in a fast‑paced environment
• Experience with electronic document control or eQMS systems
• Exposure to FDA inspections or audits
• Familiarity with ISO 13485 standards
• Experience reviewing supplier quality documentation

• Work in a general office environment
• Ability to sit for extended periods of time
• Ability to work on the computer for most of the workday
• Ability to receive and respond to telephone calls
• The employee is occasionally required to reach with hands and arms
• Must be able to lift up to 25lbs
• Eyesight and hearing must be correctable up to standard levels