Quality Assurance Manager

Full time To explore the full range of benefits please visit our website www.jmmurray.com $29.98-$37.03/hour - Placement in the range will be determined based on experience and other factors allowed by law. Description: The Quality Assurance (QA) Manager is responsible for ensuring that medical devices and pharmaceutical products comply with applicable regulatory requirements, quality standards, and company procedures. This role supports the manufacturing, validation, and post-market activities by implementing and maintaining quality systems that ensure product safety, efficacy, and compliance. The QA Manager works cross-functionally with Operations, Facilities, Maintenance, and Supply Chain to drive continuous improvement and maintain compliance with FDA, ISO, GMP, and other applicable regulations. Requirements and Experience: Bachelors degree in Biology, Chemistry, Pharmaceutical Sciences, engineering or science required. 8 or more proven years experience in Quality, Engineering, or related field in a regulated industry Pharmaceutical and/or Medical Device required. Must have demonstrated experience with ISO 9001, 21 CFR 210/211, 21 CFR 820 and ISO 13485 5 or more years of experience in interpreting these regulations and translating to quality system processes and procedures. Skills: Strong technical writing skills. Must be able to clearly document investigations, change control, etc. Strong technical, analytical, and problem-solving skills. Ability to coordinate with management on courses of action with minimal assistance using both written and verbal methods. Good interpersonal/communication/influencing/negotiation skills. Good project management skills. Working knowledge of FDA Regulations & ISO 13485 and Application of Good Manufacturing Practices. Must be able to provide solutions that reflect understanding business objectives and cost implications. Capable of working in a team-based setting providing direction and knowledge Proficiency in Microsoft Office Suite, including EXCEL and data entry with proficient use of computers and other similar devices To apply, please visit our website at www.jmmurray.com