SigmaGraft, Inc. is a rapidly growing biomedical device manufacture located in Fullerton, CA. We specialize in the production of biomaterials. These biomaterials are used by dentists to assist in bone regeneration. The SigmaGraft, Inc. team is committed to providing quality products to our customers and is continually working towards the development of new products to take to market. Our mission is to provide our customers with exceptional products of uncompromising quality. We are currently seeking a Quality Control/Quality Assurance Associate to join our team.
ESSENTIAL JOB DUTIES
• Perform routine laboratory analysis of In-Process, finished product, raw material and environmental monitoring according to established specifications and procedures
• Perform consistent qualification, calibration of production equipment
• Perform Daily Operating Inspections as needed to assure compliance with GMPs requirements
• Report and follow-up on any quality concerns
• Communicates with vendors and contract labs on various QC/QA issues and/or requests
• Assisting in variety of activities to ensure compliance with applicable quality and regulatory requirements
• Participate in developing, reviewing and maintaining documents to ensure quality objectives are met
• Performs other related duties as assigned or requested by Quality Management Representative
REQUIRED QUALIFICATIONS
• Bachelor’s degree in Chemistry, Biochemistry, Biology, Microbiology, Food Science or Material Science
• Relevant 0-2 years’ work experience in a medical device, pharmaceutical, food or aerospace field
• A strong working knowledge of Microsoft Excel, Microsoft Word, Microsoft PowerPoint and Microsoft Outlook
• Excellent communication, organizational, analytical and interpersonal skills
• Highly organized
• Flexibility and adaptability
• Ability to multi-task and prioritize multiple projects
Highly qualified candidates will also possess:
• Previous experience working with the ISO 13485 quality management system
• Previous experience with FDA requirements, knowledge of regulations such as GMP, ISO 13485 and other international regulatory requirements preferred
• Experience with ISO and/or FDA audits
• The ability to work swiftly and accurately
• The ability to recognize and solve practical problems or issues

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