Quality Engineer

Erbe USAorporated•Tempe, AZ

16d•Onsite

About The Position

This position is responsible for contributing to the development, implementation, and execution of the full product lifecycle quality management program at Erbe. As a full-lifecycle quality engineer, your job duties include creation and collaboration on design and process risk management, measurement systems analysis, design verification and validation, supplier qualification, process validation, non-conformance and CAPA, and post-market surveillance. This position is also responsible for executing to both departmental and organizational goals. 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.

Requirements

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.
Employees must be legally authorized to work in the United States.
Employees must not be specifically barred from working with Federal contracts, government entities or otherwise listed on excluded parties list as maintained by the Federal government.

Nice To Haves

ASQ Certified Quality Engineer preferred.

Responsibilities

Contributes to the development, implementation, and execution of the full product lifecycle quality management program.
Creation and collaboration on design and process risk management, measurement systems analysis, design verification and validation, supplier qualification, process validation, non-conformance and CAPA, and post-market surveillance.
Executing to both departmental and organizational goals.
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.