Sr. Quality Engineer

Essential Responsibilities

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.

• 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.

Supervisory Responsibility

This position is an individual contributor and has no direct supervisory responsibility.

Work Environment

This position operates in a professional office and manufacturing environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The position also interacts with manufacturing equipment, production processes, and finished devices on the manufacturing floor as needed to support validation, transfer, and issue resolution.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.

Position Type and Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 7:30 a.m. to 4:00 p.m. Occasional evening and weekend work may be required as job duties demand.

Travel

This position may require occasional travel, with limited international travel included.

Required Education and Experience

• Bachelor's degree in engineering, biology, biomedical technology, chemistry, or electronics.
• 5+ years' experience in quality engineering with medical devices; 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…