Sr. Quality Engineer

Erbe USA Incorporated•Tempe, AZ

10h•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, including quality planning and execution for manufacturing readiness and production transfer. 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, post-market surveillance, and cross-functional transfer of products and processes into production. This position is also responsible for executing to both departmental and organizational goals.

Requirements

Bachelor’s degree in engineering, biology, biomedical technology, chemistry, or electronics.
5+ years’ experience in quality engineering with medical devices.
Thorough understanding of full lifecycle quality engineering skillset, including design control, risk management, process validation, supplier quality, and manufacturing transfer.
Demonstrated ability to lead or support cross-functional product and process transfer activities with Engineering, Manufacturing, materials management, and suppliers.
Strong working knowledge of drawings, specifications, manufacturing records, test methods, and statistical/risk tools (e.g., MSA, FMEA, and process capability) to support quality decisions.
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

Strong preference for experience supporting manufacturing process transfer, process validation, and class II+ disposable accessories.
Experience authoring and/or reviewing validation deliverables (including IQ, OQ, and PQ), test methods, and process documentation to support production transfer preferred.
Working knowledge of FDA/QMSR, ISO 13485, ISO 14971, and applicable EU requirements preferred.
ASQ Certified Quality Engineer preferred.

Responsibilities

Interfaces with vendors (including Erbe GmbH) and in-house personnel on development of products.
Develops, revises, and/or reviews product specifications regarding contract-manufactured products (including packaging, labeling, sterilizing, biological testing, etc.) involved with Erbe USA.
Develops, revises, and/or reviews product and process risk management files.
Leads or supports supplier qualification, outsourced process validation, and ongoing supplier controls/performance reviews.
Leads or supports occasional supplier audits.
Develops, revises, and/or reviews measurement systems analysis.
Leads or supports manufacturing production transfer activities, ensuring process readiness, regulatory compliance, and quality integration across Engineering, Manufacturing, Supplier Quality, and materials management.
Authors, reviews, and/or approves validation documents and records, including IQ, OQ, and PQ protocols/reports, to support manufacturing readiness and transfer to production.
Develops and maintains process documentation to ensure manufacturing methods, inspection requirements, and procedures are clearly defined, controlled, and deployable for production.
Provides technical quality support for manufacturing processes, including evaluation of process changes to improve product quality, yield, throughput, and overall equipment/process efficiency.
Collaborates on test method development and reviews testing methodologies, equipment, and documentation to confirm conformance to established standards and specifications.
Works with drawings, specifications, and manufacturing records to ensure complete and accurate transfer of product requirements into production.
Applies statistical methods and FMEA-based risk tools to support process capability, validation effectiveness, and quality decision-making during product and process transfer.
Leads or supports post-market surveillance activities.
Supports the development of regulatory submissions.
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 and process documentation (i.e., inspection/testing documentation, work instructions, SOPs, and related records).
Performs and documents training.
Additional duties as assigned by Manager.