Quality Specialist | Salt Lake City,UT
Nexeo Staffing
SALT LAKE CITY, UT
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JOB DETAILS
SALARY
LOCATION
SALT LAKE CITY, UT
POSTED
30+ days ago
Nexeo 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 company s 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 needed
Qualifications
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 culture
Pay
$28.95 per hour
Schedule
Monday Friday | 8:00 AM 5:00 PM
Nexeo Benefits
Medical,Dental,Vision,Limited Life,Short-Term Disability.
Refer a Friend Bonus | Other Financial Incentives (Bonuses).
Weekly Pay | Direct Deposit | Rapid Pay Card.
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1745 W 7800 S,West Jordan,UT 84088
(P) (801) 305-1300
Nexeo 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 trai ing.
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 shift
INDWJ
About the Company
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