Responsibilities: • 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
Required Skills: • 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.
Others: • 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)