Hollister Incorporated · 2 days ago
Plant Quality Engineer III
Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The role of Plant Quality Engineer III involves supporting the plant manufacturing facility in ensuring quality products, meeting regulatory compliance requirements, and partnering with operations to achieve plant objectives.
Health CareManufacturing
Responsibilities
Act as Quality Resource to help facilitate completion of assigned Change Controls
Lead and perform pFMEA and products/process qualifications
Review, evaluate and disposition non-conforming materials
Respond to assigned CAPAs and QNs for investigation, root cause analysis and implement solutions
Plan, coordinate, execute and document process capability, validation studies, and process improvement studies
Create, execute and conclude results for protocols, including final reports and summaries
Support Operations and GQM strategic plans in leading or supporting projects
Plan, coordinate, and document Quality Plans and work instructions
Conduct training on defect awareness
Work collaboratively with Value Stream Process Engineers to identify, investigate and solve quality issues
Responsible for achieving competency in all identified skill requirements outlined in associated training profile for position
Other duties and tasks as assigned
Qualification
Required
Act as Quality Resource to help facilitate completion of assigned Change Controls
Lead and perform pFMEA and products/process qualifications
Review, evaluate and disposition non-conforming materials
Respond to assigned CAPAs and QNs for investigation, root cause analysis and implement solutions
Plan, coordinate, execute and document process capability, validation studies, and process improvement studies
Create, execute and conclude results for protocols, including final reports and summaries
Support Operations and GQM strategic plans in leading or supporting projects
Plan, coordinate, and document Quality Plans and work instructions
Conduct training on defect awareness
Work collaboratively with Value Stream Process Engineers to identify, investigate and solve quality issues
Responsible for achieving competency in all identified skill requirements outlined in associated training profile for position
Prolonged periods of sitting
Ability to interface with a computer for long periods of time
Frequent movement over large manufacturing floor areas
Occasionally move products/parts from production floor into testing area, up to 20 pounds
Travel requirements
Ability to train/facilitate
Flexible work schedule with start/stop times across all shifts
Communication skills, both written and oral
Number of Overall Years Necessary: 0-5 years
Preferred
Experience in Quality Engineering or equivalent industry disciplines
Experience in medical device manufacturing regarding Quality System requirements per 21 CFR 820 and/or ISO 13485
Bachelor's Degree in Science (Engineering, Math, Natural Sciences, or related study)
Knowledge and application of basic statistics and experimental design
Knowledge and experience in statistical software packages (ex. Minitab)
Technical writing skill
Experience working with self-directed work teams
Experience performing internal/external audits and evaluations
Experience with product design and product design related regulatory requirements
Knowledge and implementation of medical device Quality System requirements (FDA and ISO)
ASQ Certified Quality Engineer
Knowledge of Lean and Six Sigma Black Belt principles
Advanced technical writing skills
Knowledge of SAP/ERP Systems
Knowledge of Microsoft Office Products (Word, Excel, Project, Access, PowerPoint)
Company
Hollister Incorporated
Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets healthcare products and services worldwide.
H1B Sponsorship
Hollister Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (2)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
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