As part of the SigmaGraft Quality Department, the Quality Assurance Specialist is responsible for supporting the effective implementation and continuous improvement of the Company's Quality Management System (QMS). This position works closely with Quality Control, Operations, Regulatory Affairs, and other departments to ensure compliance with applicable regulations, standards, and internal procedures. Key Responsibilities Create, revise, and maintain Quality Management System procedures, work instructions, forms, and guidance documents. Coordinate and maintain the Company's document control system. Review incoming inspection records for raw materials and packaging components. Review and approve raw material and packaging component specifications. Review and approve routine facility inspection records conducted by the Quality Control Department. Review and issue Certificates of Conformance (CoC) for products released to customers. Assist in supplier qualification, evaluation, and ongoing monitoring activities. Review product batch records and supporting documentation prior to product release. Assist in investigations related to customer complaints, nonconforming products (NCRs), audit findings, deviations, and Corrective and Preventive Actions (CAPAs). Supervise and provide guidance to Quality Control Inspectors. Support internal and external audits as required. Participate in continuous improvement initiatives to enhance quality system effectiveness. Perform other duties as assigned. Qualifications Knowledge and Skills Strong attention to detail and excellent organizational skills. Ability to learn quickly and manage multiple priorities in a fast-paced environment. Excellent time management skills with the flexibility to adapt to changing priorities. Strong analytical and problem-solving abilities. Excellent written and verbal communication skills in English. Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat. Ability to work effectively in a diverse, multicultural team environment. Knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, GMP, or other regulated quality systems is preferred. Experience with document control, investigations, CAPA, audits, and product release activities is preferred. Education and Experience Bachelor's degree in Biology, Chemistry, Biomedical Engineering, Life Sciences, Engineering, or another related scientific discipline. Minimum of two (2) years of experience in a GMP-regulated manufacturing environment, preferably in the medical device, pharmaceutical, tissue, biologics, or biotechnology industry. Experience working with Quality Management Systems (QMS) is preferred.

Job Type:

Full-time Pay:

From $27.00 per hour

Benefits:

401(k) 401(k) matching Health insurance Paid time off

Work Location:

In person