Erbe USA Incorporated · 17 hours ago
Quality Engineer II
Tempe, Arizona, United States
Full-time
Onsite
Mid Level
3+ years expErbe USA Incorporated is a company focused on quality standards in the medical industry. They are seeking a Quality Engineer II to create and implement quality standards, provide technical support for manufacturing processes, and ensure compliance with regulatory requirements.
Health CareMedical
Responsibilities
Creates, revises, and implements quality standards as well as procedures [i.e., Standard Operating Procedures (SOPs), etc.] in accordance with established Erbe Quality system
Implement and evaluate changes to existing processes designed to improve product quality, productivity and overall equipment efficiency
Develop and maintain process documentation ensuring that processes and procedures are clearly stated and understandable for all employees
Provide technical support/solutions to manufacturing processes, improve yield and throughput, drive cost reduction activities and improve on part quality
Demonstrated ability to start-up, operate and shut down process related equipment. Must be able to work independently on new process development as well as troubleshooting current production issues
Monitor and report issues with tooling, make recommendations for refurbishment based on production factors such as cycles, process capability and tooling history
Interact with stakeholders to resolve issues and provide project updates
Implement technical solutions including statistical methodology to meet cost, quality, and delivery expectations
External and internal Supplier Quality experience
Author validation documents and records including IQ, OQ and PQ reports and protocols
Drive Design Control Processes including Verification and Validation Activities
Test Method Development
Conduct Risk Management and FMEA activities, ensuring risks are identified, evaluated, mitigated, and documented per ISO 14971 and related standards
Work with Design files including drawings, specifications and records
Collaborate cross-functionally with Engineering, Manufacturing, materials management, and other functional groups to ensure product transfer, regulatory compliance, and quality integration
Evaluates and establishes controls for all suppliers/vendors who have an impact on product quality; conducts initial assessments as well as yearly performance reviews to convey and resolve quality issues as they arise
Reviews testing methodologies, equipment, documentation, etc. for appropriateness to demonstrate that conformance to established standards and/or specifications
Reviews product and system failures to determine root causes with recommendations for corrective/preventive measures. Identifies preventive actions to minimize/eliminate potential problems. Verifies implementation and effectiveness of solutions to quality related issues
All other duties as assigned by the Quality Manager
Qualification
Required
Bachelor's degree in engineering, science, or related area of study required
3-5 years' experience in the medical industry experience in quality control and quality assurance in a Manufacturing setting particular working with Injection Molding and ancillary processes (i.e. bonding, printing, joining, laser welding, assembly, packaging)
Competence in applying and assuring compliance to QSR and EU Requirements as well as applicable current International Standards desired
Working knowledge of medical device sterilization processes (e.g., EO), including validation support, routine monitoring, and sterilization-related investigations is preferred
Diverse technical background in injection molding processing, tooling, equipment, materials, manufacturing and quality including validations (IQ, OQ, PQ)
Knowledge of applicable regulatory standards is required
Excellent verbal and written communications required; strong facilitation and interpersonal skills required
Thorough understanding of research and development, validations, quality and regulatory are necessary with operations and quality systems auditing capabilities
Must be able to communicate complex information to all levels within the organization
Demonstrated high quality computer skills including MS Office and some exposure to electronic quality systems
Must be detail-oriented and produce high quality work in a high-volume environment
Must be able to handle confidential information in an appropriate and professional manner
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
Preferred
Working knowledge of medical device sterilization processes (e.g., EO), including validation support, routine monitoring, and sterilization-related investigations is preferred
Lean Six Sigma Green Belt and experience is preferred
ASQ Certification is 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