Arden, North Carolina, United States · On-site
$75k–$80k/yr
Owens & Minor is a global healthcare solutions company providing essential products, services and technology solutions that support care delivery in leading hospitals, health systems and research centers around the world…
Skills: Master Validation Plan, Statistical Rationale, Sterilization Validation, Aging Studies, Risk Analysis
Winston-Salem, North Carolina, United States · On-site
If you are a GPI employee, please click the Employee Login before applying. At Graphic Packaging International, we produce the paper cup that held your coffee this morning, the basket that transported those bottles of cr…
Skills: Manufacturing Experience, Quality Control, Machine Feeding, Manual Sorting, Reading Technical Documents
Holly Springs, North Carolina, United States · On-site
Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facil…
Skills: cGMP, Biomanufacturing, Process Monitoring, In-process Testing, Validation Protocols
Marion, North Carolina, United States · On-site
$53k–$73k/yr
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues …
Skills: CNC Milling, CNC Lathe, Blueprint Reading, G-Code, MasterCam
Kinston, North Carolina, United States · Hybrid
Airbus is committed to providing reasonable accommodations as an Equal Opportunity Employer to applicants with disabilities. If you require assistance or an accommodation to complete your application, please contact us a…
Skills: Industrial Architecture, Production Planning, SAP, Composite Manufacturing, Metallic Manufacturing
Shelby Township, Michigan, United States · On-site
Westlake offers you the potential to enrich your work life and career experience in an entrepreneurial environment. We work together to enhance peoples' lives through our products and presence in the communities in which…
Skills: Material Handling, Forklift Operation, Inventory Management, 5S Methodology, Communication Skills
Salisbury, North Carolina, United States · On-site
About Us We are a leading industrial mechanical, electrical, and civil construction services provider for the fossil and nuclear power, pulp and paper, chemical, mining, and general manufacturing industries. We provide a…
Skills: Pipe Welding, Blueprint Reading, Tig Welding, Mig Welding, Stick Welding
Morrisville, North Carolina, United States · On-site
Company Overview At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies,…
Skills: UPLC, HPLC, Capillary Electrophoresis, icIEF, Protein Mass Spectrometry
Charlotte, North Carolina, United States · Hybrid
$110k–$130k/yr
Xylem is a Fortune 500 global water solutions company dedicated to advancing sustainable impact and empowering the people who make water work every day. As a leading water technology company with 23,000 employees operati…
Skills: Employee Relations, Workforce Planning, Performance Management, Talent Acquisition, HR Compliance
Rocky Mount, North Carolina, United States · On-site
$22/hr–$26/hr
Job TitleMaintenance Technician II - 3rd Shift Job Description SummaryJob Description Shift Schedule: Sunday through Thursday | Overnight: 9:00 PM–5:30 AM Our Purpose: At C&W Services, we live by the belief that Better N…
Skills: Material Handling Equipment Repair, Preventative Maintenance, Electrical Troubleshooting, Mechanical Troubleshooting, Blueprint Reading
Charlotte, North Carolina, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail …
Skills: Technical Support Leadership, Problem Solving, Analytical Skills, Written and Verbal Communication, CRM Systems
Gaston County, North Carolina, United States · On-site
Pump Mechanic Join the Voigt-Abernathy Team Voigt-Abernathy is a leading distributor and service provider of industrial rotating and process equipment throughout the Southeast. We specialize in pumps, pumping systems, se…
Skills: Pump Maintenance, Pump Repair, Troubleshooting, Mechanical Aptitude, Hand Tools
Cornelius, North Carolina, United States · Hybrid
About Us: How many companies can say they’ve been in business for over 179 years?! Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting i…
Skills: 3D Scanning, CT/Xray Solutions, Metrology, Robot Cell Programming, ZEISS Inspect Pro
Fletcher, North Carolina, United States · On-site
Characteristics of the Class: Acquire a working knowledge of all positions in the melamine department. Ensure that material is being run to the correct specifications set forth in the ISO procedures. Provide assistance i…
Skills: Machinery Operation, Safety Procedures, Quality Control, Hazardous Material Handling, Tape Measure Reading
Fletcher, North Carolina, United States · On-site
Characteristics of the Class: Cut dry decorative patterns into specific lengths with an emphasis on quality. Essential Duties and Responsibilities: 1. Prioritize material needed to be cut daily. 2. Set up material to be …
Skills: Material Cutting, Quality Control, Tape Measure Reading, Computer Literacy, Equipment Operation
Holly Springs, North Carolina, United States · On-site
Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facil…
Skills: cGMP Manufacturing, Process Monitoring, In-process Testing, Validation Protocols, SOP Execution
Charlotte, North Carolina, United States · On-site
$98k–$144k/yr
About Us Schweitzer Engineering Laboratories (SEL) designs and builds products and systems that protect, control, and automate power systems worldwide. Our mission is to make electric power safer, more reliable, and more…
Skills: React, TypeScript, C#, ASP.NET, REST
Asheville, North Carolina, United States · On-site
A Machine Operator ensures that the final product aligns with the company's quality standards which includes the reliability, usability and performance of the product. In general, these meticulous professionals are accou…
Skills: Machine Operation, Quality Control, Troubleshooting, Routine Maintenance, Micrometers
Mecklenburg County, North Carolina, United States · On-site
$64k–$88k/yr
Requisition Number: 75878 The company built on breakthroughs. Join us. Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of…
Skills: Optical Testing, Fiber Splicing, Project Leadership, Technical Writing, Technical Support
Holly Springs, North Carolina, United States · On-site
$115k–$156k/yr
Career CategoryEngineeringJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious…
Skills: Clean Utilities Design, Commissioning And Qualification, GMP Compliance, Root Cause Analysis, Predictive Maintenance
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The Quality Engineer manages the master validation plan and optimizes business processes to improve operational effectiveness. They serve as a subject matter expert for new product and machine validations, sterilization, and risk analysis.
A Bachelor's degree in Engineering or a technical field is required, along with four to six years of quality experience. Preference is given to candidates with medical device experience, ISO 13485 knowledge, and Green/Black Belt certification.
Owens & Minor is a global healthcare solutions company providing essential products, services and technology solutions that support care delivery in leading hospitals, health systems and research centers around the world. For over 140 years, Owens & Minor has delivered comfort and confidence behind the scenes, so healthcare stays at the forefront, helping to make each day better for the hospitals, healthcare partners, and communities we serve. Powered by more than 14,000 teammates worldwide, Owens & Minor exists because every day, everywhere, Life Takes Care™.
140+ years serving healthcare
Over 14,000 teammates worldwide
Serving healthcare partners in 80 countries
Manufacturing facilities in the U.S., Honduras, Mexico, Thailand and Ireland
40+ distribution centers
Portfolio of 300 propriety and branded product offerings
1,000 branded medical product suppliers
4,000 healthcare partners served
Comprehensive Healthcare Plan - Medical, dental, and vision plans start on day one of employment for full-time teammates.
Educational Assistance - We offer educational assistance to all eligible teammates enrolled in an approved, accredited collegiate program.
Employer-Paid Life Insurance and Disability - We offer employer-paid life insurance and disability coverage.
Voluntary Supplemental Programs – We offer additional options to secure your financial future including supplemental life, hospitalization, critical illness, and other insurance programs.
Support for your Growing Family – Adoption assistance, fertility benefits (in medical plan) and parental leave are available for teammates planning for a family.
Health Savings Account (HSA) and 401(k) - We offer these voluntary financial programs to help teammates prepare for their future, as well as other voluntary benefits.
Paid Leave - In addition to sick days and short-term leave, we offer holidays, vacation days, personal days, and additional types of leave – including parental leave.
Well-Being – Also included in our offering is a Teammate Assistance Program (TAP), Calm Health, Cancer Resources Services, and discount programs – all at no cost to you.
The Quality Engineer uses their personal experience and judgment applying
learned engineering methodologies and other analytics to initiate, implement,
and manage the master validation plan within the facility. The Engineer will have
responsibility for improving operational effectiveness through the refinement of
existing procedures or business processes to optimize validations. The Quality
Engineer will be a key resource for new product and machine validations
providing subject matter expertise.
Creates, manages and improves the Master Validation Plan; designs protocols that utilize proper sampling techniques, strong design of experiments and tests and will provide statistical rationale.
Conducts validation or qualification tests on new or existing equipment, processes or software in accordance with internal protocols or external standards.
Conducts sterilization validations in accordance with internal protocols and external standards. Supports activities related to the master sterilization plan.
Develops and manages aging studies for packaging which may include coordinating testing, analyzing data and documenting results.
Leverages various software programs such as Word, Excel, SAP, Minitab and other necessary programs or project tools to manage and analyze data and complete work.
Provides analysis and interpretation of report data including the use of systems.
Leads Risk Analysis.
Responsible for KPI improvement on the production floor.
SME for Change Control.
Performs additional duties as directed
Bachelor’s degree (B.S.) in Engineering or other technical degree from a four-year college or university is required.
Four to six years of experience in the Quality field is required.
Three to five years of experience in a manufacturing environment
preferred.
Green/Black Belt Certification or Lean Manufacturing training preferred.
Medical Device experience, knowledge of ISO 13485, sterilization, and Minitab experience a preferred.
#LI-MV1
If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.
Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.
Owens & Minor is a global healthcare solutions company providing essential products, services and technology solutions that support care delivery in leading hospitals, health systems and research centers around the world. For over 140 years, Owens & Minor has delivered comfort and confidence behind the scenes so healthcare stays at the forefront, helping to make each day better for the hospitals, healthcare partners, and communities we serve. Powered by more than 14,000 teammates worldwide, Owens & Minor exists because every day, everywhere, Life Takes Care™
Offices: 10900 Nuckols Rd, Suite 400, Glen Allen, Virginia 23060, US
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