• Complete Quality Control documentation for production and distribution in accordance with organizational procedures, SOPs, current Good Tissue Practices, FDA and other regulatory requirements
• Lead by example and enforce Good Documentation Practices within operations
• Support Quality activities in production and distribution for equipment qualification, including calibration and preventive maintenance activities
• Support documentation and processes in compliance with the Quality System
• Uphold regulatory guidelines set forth by the FDA, AATB, HHS, and OSHA
• Bachelor’s degree, specialization in science, engineering, or related technical field preferred
• Minimum 2 years of experience working within an FDA regulated industry (e.g., Medical Device, Pharmaceutical, HCT/P).
• Understanding of 21 CFR 820 and/or 1271, ISO 13485, AATB Standards, and ISO 14971 preferred.
• Self-motivator with an analytic nature.
• Strong organizational, communication, and interpersonal skills.
• Must have experience working in MS Office Software Suite, and ERP/MRP management software experience is a plus.
• Ability to obtain Quality training and/or certifications as needed.
• Candidates will deal with documentation, quality packaging slips and ensure logs match
• Document and inspect new products
• Help with packaging and labeling
• Work in a collaborative environment (15-20 members per team)