Quality Assurance Associate

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)