Hiring: Quality Systems & Compliance Manager Company: Phoenix VX Location: Dougherty County, GA Job Posted Time: 2026-09-16 11:19:06 Target Skills & Keywords : Phoenix, Quality Assurance, Regulatory Compliance, SAP About the job Experience: •8+ years of Quality experience** within a regulated manufacturing environment strongly preferred. Required Skills: •Lead and maintain the site's Quality Management System (QMS) and associated compliance programs supporting medical device manufacturing and product release. •Serve as a key site owner and administrator for Change Control, including Quality approval and assessment of proposed changes. •Oversee Document Control, controlled documentation, quality records, investigations, deviations, CAPAs, and associated QMS workflows. •Review and approve investigations and corrective/preventive actions, ensuring appropriate root-cause analysis, effectiveness checks, documentation quality, and timely closure. •Maintain a high level of inspection and audit readiness across the manufacturing site. •Lead and support internal audits, supplier audits, regulatory inspections, and external audit activities, including responses and corrective actions. •Monitor Quality System performance and develop quality metrics, trend reports, compliance indicators, and management review information. •Ensure applicable Quality processes align with ISO 13485, 21 CFR medical device requirements, EU MDR 2017/745, ISO 14971, and other applicable regulatory standards. Qualifications: •Demonstrated hands-on experience with **Quality Systems**, particularly Change Control, Document Control, investigations, CAPA, audits, and Quality records. •Solid functional working knowledge of **GMP requirements and Quality Management System principles**. •Medical device manufacturing experience is **strongly preferred but not required** for an otherwise highly qualified Quality Systems professional. •Knowledge of **ISO 13485, 21 CFR medical device regulations, EU MDR 2017/745, and ISO 14971** is highly desirable. •Previous leadership or supervisory experience, including responsibility for developing Quality or laboratory personnel. •Bachelor's degree in **Life Sciences, Engineering, Chemistry, Biology, Quality, or a related technical discipline** preferred; substantial relevant industry experience may be considered in lieu of a degree. •Strong written and verbal communication skills with the ability to work effectively across Operations, Quality, Regulatory, Supply Chain, and senior leadership. •Demonstrated ability to manage multiple Quality initiatives, establish priorities, resolve compliance issues, and meet critical deadlines. Compensation: •$100,000 - $115,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!