Quality Engineer Jobs

About The Position

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.