Erbe USA Incorporated · 7 hours ago
Quality Engineer
Tempe, AZ
Full-time
Onsite
Entry, Mid Level
2+ years expErbe USA Incorporated is a company focused on quality management in the medical device industry. They are seeking a Quality Engineer to contribute to the full product lifecycle quality management program, including risk management, validation, and compliance with regulatory standards.
Health CareMedical
Responsibilities
Interfaces with vendors (including Erbe GmbH) and in-house personnel on development of products
Develops, revises, and/or reviews product specifications regarding manufactured products (including packaging, labeling, sterilizing, biological testing, etc.) involved with Erbe USA
Conduct Risk Management and FMEA activities, ensuring risks are identified, evaluated, mitigated, and documented per ISO 14971 and related standards
Leads or supports supplier qualification and outsourced process validation
Leads or supports occasional supplier audits
Develops, revises, and/ or reviews measurement systems analysis
Leads or supports post-market surveillance activities
Supports the development of regulatory submissions
Collaborate cross-functionally with Engineering, Manufacturing, materials management, and other functional groups to ensure product transfer, regulatory compliance, and quality integration
Support Process/Product Monitoring and Validation, including IQ/OQ/PQ protocols, statistical process control (SPC), process capability assessments, and process validation
Troubleshoots product non-conformances/failures to determine root causes and provides recommendations for corrective/preventive measures (Includes identifying, documenting, and recommending solutions to the quality problem)
Identifies preventive actions to minimize/eliminate potential non-conformances or problems. Verifies implementation and effectiveness of solutions to quality related issues
Creates, revises, and implements quality procedures (i.e., inspection/testing documentation, work instructions, etc.)
Performs and documents training
Performs all other duties as assigned by the Quality Manager
Qualification
Required
Bachelor's degree in biology, biomedical technology, chemistry, electronics or engineering
2 + years' experience in medical device quality management; strong preference for experience with disposable instrumentation
Thorough understanding of full lifecycle quality engineering skillset
Excellent verbal and written communications required; strong facilitation and interpersonal skills required
Must be able to communicate complex information to all levels within the organization
Demonstrated high quality computer skills including MS Office (particularly Excel), Outlook and some exposure to electronic quality systems
Must be highly detail-oriented and produce high quality work in a high-volume environment
Must be able to work independently using experience and judgment to make sound decisions
Preferred
ASQ Certified Quality Engineer preferred
Company
Erbe USA Incorporated
Established in 1992 and located in Marietta, Georgia, a suburb of Atlanta, Erbe USA, Incorporated is the North American headquarters for its parent company, Erbe Elektromedizin GmbH, based in Tübingen, Germany.
51-200 employees
H1B Sponsorship
Erbe USA 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Mark O'Sullivan
President & CEO
Recent News
2025-01-04
Company data provided by crunchbase