<p>Quality Assurance Specialist II</p> <p>Date: Mar 20, 2025</p> <p>Location(s):</p> <p>Mt. Juliet, TN, US, 37122</p> <p>Location(s):</p> <p>Mt. Juliet, TN, US, 37122</p> <p>Company: Hollister Incorporated</p> <p>We Make Life More Rewarding and Dignified</p> <p>Location: Nashville</p> <p>Department: Quality</p> <p>Summary</p> <p>Support the facility Quality System to meet all regulatory compliance requirements, by handling procedures and records, supporting the preparation and implementation of audits and partnering with operations in achieving both facility and Global Quality objectives compatible with Hollister's Mission and Vision.</p> <p>Responsibilities</p> <ul> <li>Support global compliance related projects as local DC representation and liaison for change control and impact communication </li><li>Facilitate root cause investigations for all external complaints and internally raised quality related issues to coordinate corrective actions including roving audit findings </li><li>Generate Certificates of Conformance and Certificate of Analysis </li><li>Support efforts to maintain the Continuous Improvement methodology by attending daily tier meetings, routinely completing Gemba walks, supporting HPS element activities </li><li>Support creation, revision, training for, and control of Standard Work documents </li><li>Manage e-doc workflows for creation and revision of quality-controlled documentation to ensure facility procedures meet corporate guidelines, ISO and FDA requirements </li><li>Manage LMS training curricula and perform associate training for quality procedures, GDP, and orientation </li><li>Conduct internal audits to support the annual schedule </li><li>Manage the calibration system and monitor the preventive maintenance system </li><li>Support root cause investigation and action items for local CAPAs </li><li>Participate as needed in regulatory audits e.g. ISO & MDSAP </li><li>Participate as needed in supplier audits </li><li>Ad hoc job related duties as determined and assigned by management </li></ul> <p>Essential Functions of the Role</p> <ul> <li>Good attention to detail </li><li>Good report writing skills </li><li>Team player </li><li>Proficient Computer skills </li></ul> <p>Work Experience Requirements</p> <ul> <li>Number of Overall Years Necessary: 2-5 </li></ul> <p>Education Requirements</p> <ul> <li>Minimum of a Bachelors degree in medical device engineering Pharma/ Food Science / Medical Device or other Technical Areas by education or experience. </li></ul> <p>Specialized Skills/Technical Knowledge</p> <ul> <li>Excellent communications skills </li><li>Auditor Training - Preferred </li><li>Basis technical writing skills </li><li>Knowledge of ISO 13485 /GMP/GDP preferred </li></ul> <p>About Hollister Incorporated</p> <p>Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.</p> <p>EOE Statement</p> <p>All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.</p> <p>Job Req ID: 34406</p> <p>Nearest Major Market: Nashville</p> <p>Job Segment: Facilities, Technical Writer, Quality Assurance, Compliance, Law, Operations, Technology, Legal</p>