Greiner Bio-One Americas · 21 hours ago
Quality Engineer II
Monroe, NC
Full-time
Onsite
Entry, Mid Level
2+ years expGreiner Bio-One Americas is seeking a Quality Engineer II to develop and maintain quality processes in compliance with ISO and FDA regulations. The role involves leading investigations, authoring technical reports, and driving quality improvements in the manufacturing process.
Biotechnology
Responsibilities
Develop, maintain and monitor quality processes to ensure compliance to ISO and FDA regulations
Quality representation for the development of new products and processes including evaluation of technical drawings, test methodologies, and validation to ensure compliance
Lead non-conformance investigations along with other departments to identify root cause and assure nonconforming products dispositioned properly
Presents findings of trend review or nonconformances to team and/or management staff
Author technical reports regarding nonconformance and complaint investigations as well as effectiveness reports for completed CAPA
Completion of risk assessment such as pFMEA to identify risks to product for determining the concession release of material through the Material Review Board
Assist in determining quality improvements by using relevant statistical method to testing methodologies and/or manufacturing processes and leading improvement projects for safety, quality, and productivity based on findings
Represent Quality in change control process, validation, and continuous improvement activities for the Production and Quality Control departments as assigned
Analysis of Quality trends and reporting on them for management review as well as escalation of identified trends
Create, review and approve fixture designs and prototypes
Monitor the effectiveness of employee training required in the inspection processes
Author SOPs, test procedures, validation protocols and reports
Author engineering studies using scientific principles
Performs tasks accurately and with great attention to detail
Other duties as assigned
Qualification
Required
Bachelor's degree in engineering field or related field
2-5 years of experience in high volume regulated manufacturing industry in engineering field
Working experience of Six Sigma, lean and Quality Management Tools
A broad knowledge of theory and principles of statistics and statistical process control
Experience with Access Database, Excel and complaint handling software
Basic knowledge of medical device regulation, industry, and international standards
Strong computer skills including QA applications, word processing, spreadsheets and databases
Ability to recognize and define problems, collect data, and develop conclusions
Ability to read and understand technical drawings and documents
Working experience on CAD/SolidWorks
Ability to work independently and take initiative
Excellent communication, analytical, trouble-shooting and interpersonal skills
A team player as well as the ability to work independently
Company
Greiner Bio-One Americas
Greiner Bio-One specializes in the development, production and distribution of high-quality plastic laboratory products.
1001-5000 employees
H1B Sponsorship
Greiner Bio-One Americas 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (1)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Michael Johnson
Human Resources Business Partner
Recent News
2025-07-04
2025-06-26
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