Quality Engineer II

• 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.

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

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, and stoop; use hands to finger, handle or feel; and reach with hands and arms.

The employee frequently is required to lift and/or carry up to 20 pounds. For more information, please refer to the Position Analysis/Physical Activities Checklist on file in Human Resources.

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

This position requires no measurable travel.

• 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…