QA/QC Specialist

Key Responsibilities

• Work under the direction of the Quality Systems, Regulatory, or Radioassay leadership to support and maintain compliance with established quality programs.
• Provide regular updates on QA and QC activities through reports and team discussions.
• Support the upkeep of a compliant Quality Management System aligned with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR 820, NRC, BIS, DOT, ISO 17025, CE Mark, and other applicable regulatory standards.
• Aid in ongoing regulatory compliance requirements and updates as needed.
• Perform final quality checks across product lines and review outgoing orders, with exceptions as directed by leadership.
• Manage nonconformance reports (NCRs), including issuance, tracking, resolution, and documentation.
• Maintain accurate filing and organization of all quality records and documentation.
• Monitor production activities to ensure adherence to established procedures.
• Identify opportunities for process improvements and recommend updates where appropriate.
• Conduct incoming inspections of materials and components.
• Verify accuracy and readability of engravings completed internally or by external vendors.
• Support dimensional inspections of manufactured components.
• Review domestic and international orders for regulatory and license compliance.
• Assist in managing document control systems and processes.
• Update and revise quality documentation, including procedures, forms, drawings, and records.
• Maintain documentation systems and tools such as BPM platforms, eQMS, or document management software.
• Support approval of design documentation and engineering change orders.
• Maintain technical files for regulated products.
• Participate in internal and supplier audits under the supervision of a lead auditor.
• Provide training to staff on quality procedures and inspection methods as needed.
• Travel periodically between local facilities and to supplier sites for audits or training.
• Perform additional responsibilities as assigned.

Qualifications

• High school diploma required; associate or bachelor’s degree preferred.
• At least 3 years of experience in quality control or quality assurance.
• Prior exposure to documentation control, record keeping, or inventory tracking is preferred.

Skills and Experience

• Strong written and verbal communication skills.
• High level of attention to detail and accuracy.
• Experience using inspection tools such as calipers, micrometers, and optical measurement equipment.
• Ability to perform final inspections and receiving inspections independently.
• Comfortable working both independently and collaboratively.
• Strong organizational skills with the ability to manage shifting priorities.
• Proficient in Microsoft Excel, Word, and Access.
• Ability to lift up to 50 pounds.
• Willingness to travel between local sites as needed.