Quality Specialist | Salt Lake City, UT

Quality Specialist | Salt Lake City, UTNexeo HR is now hiring a Quality Specialist for a high-volume, large-scale medical manufacturing and molding facility specializing in IV therapy products, including IV sets and needle-free connectors. This FDA-regulated site plays a key role in the companys global supply chain, supporting medical device operations across North and Central America. Join a team committed to compliance, quality assurance, and cleanroom production standards, offering long-term, stable employment in a fast-paced, safety-driven environment.Responsibilities    Evaluate Engineering Change Orders (ECOs) and function as a Change Analyst, ensuring full alignment with internal Change Control procedures and ISO/GMP regulatory standards    Track and analyze product documentation using Quality Management System (QMS) data    Perform advanced documentation queries in Oracle, SQL, and other electronic systems    Organize and maintain accurate records for current and historical documentation, batch records, and specifications    Support specification control, document versioning, and batch record maintenance activities    Conduct internal documentation audits (planned and unplanned) to ensure FDA and cGMP compliance    Participate in process improvement initiatives across quality and manufacturing teams    Review and revise departmental Standard Operating Procedures (SOPs) and Work Instructions    Attend cross-functional meetings supporting new product introductions (NPI) and product conversions    Develop, revise, and maintain training materials and learning content for Change Control processes    Provide training, troubleshooting, and user support for documentation tools and Quality Procedures    Ensure physical and digital records are managed per document retention regulations    Actively support the site during FDA audits, ISO inspections, and internal regulatory reviews    Complete special assignments and cross-departmental documentation tasks as neededQualifications    Strong understanding of FDA regulations, ISO 13485, cGMP standards, and medical device documentation requirements    Experience in technical writing, documentation control, and change management    Proficient with Oracle, SQL, Power Query, Visual Basic, and document control software    Familiar with Distributed Documentation systems, product specification structures, and quality system workflows    Excellent written and verbal communication skills    Ability to analyze and synthesize complex documentation requirements    Prior experience supporting regulatory inspections, including FDA or ISO audits    Detail-oriented with exceptional organizational and time management skills    Willingness to learn new systems and contribute to a continuous improvement culturePay$28.95 per hourScheduleMondayFriday | 8:00 AM5:00 PMNexeo Benefits    Medical, Dental, Vision, Limited Life, Short-Term Disability.    Refer a Friend Bonus | Other Financial Incentives (Bonuses).    Weekly Pay | Direct Deposit | Rapid Pay Card.    Hassle-Free Job Search: A Nexeo Recruiter is always available to assist you. Questions?Call or Text our office todayWith 100+ jobs available, we're sure to find a job for you.1745 W 7800 S, West Jordan, UT 84088(P) (801) 305-1300Nexeo provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, or genetics. In addition to federal law requirements, Nexeo complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.Nexeo expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status.salt lake city | quality specialist | documentation specialist | change analyst | change control | engineering change orders | batch records | specification control | document retention | technical writing | oracle | sql | visual basic | power query | fda | cfr 820 | iso 13485 | gmp | cgmp | qms | sops | work instructions | new product introduction | medical devices | iv therapy | needle-free connectors | regulatory audits | internal audits | medical manufacturing | molding | cleanroom | quality assurance | full-time | day shiftINDWJ