Greiner Bio-One Americas · 1 day ago
Senior Quality Engineer
Monroe, NC
Full-time
Onsite
Mid, Senior Level
3+ years expGreiner Bio-One Americas is seeking a Senior Quality Engineer to ensure product quality and compliance with industry standards. The role involves developing inspection methods, leading process improvements, and collaborating with suppliers to address quality issues.
Biotechnology
Responsibilities
Set detailed guidelines on inspection and testing requirements
Ensure products adhere to company and industry quality standards
Develop inspection methods to analyze product quality
Identify and lead CAPA and process improvement initiatives
Develops, maintains and monitor measurement processes to ensure compliance to ISO and FDA regulations
Collaborate with supplier to investigate root cause and corrective actions when raw material or component deficiencies are detected
Monitor and evaluate supplier process for compliance to purchase order and engineering requirements
Deploy variation management tools and techniques at select suppliers to mitigate risk
Audit suppliers and establish supplier quality requirements
Reporting on supplier trends for management review and notification of identified trends to management for management review
Design and implements methods for process control, process improvement, testing, and inspection
Establish and maintains process flow diagrams, workplace layouts, FMEAs and standardize work instructions
Other duties as assigned
Qualification
Required
Bachelor's degree in engineering field or related field
3-7 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
In-depth knowledge of ISO13485, ISO14971, CFR part 820
Good understanding of medical device regulation, industry, and international standards
Strong computer skills in MS Office
Ability to recognize and projects
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
ASQ Lead Auditor or equivalent training in auditing
A team player as well as the ability to work independently
Must be able to work overtime as needed
Must be able to sit, stand and walk for up to 8 hours
Must be able to lift up to 70 lbs
Preferred
Master's degree in engineering is preferred
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
Company data provided by crunchbase