Quality Engineer - Medical Devices

Our client seeks an innovative and forward-thinking Quality Engineer - Medical Devices. The Quality Engineer - Medical Devices will lead the company’s validation program. Additional responsibilities include authoring protocols, executing validation protocols and writing reports. Attention to detail is critical as the Quality Engineer - Medical Devices must insure that validation best practices and compliance expectations are integrated in all work performed by the team.

• Handle the quality engineering duties associated with new product development, design controls, quality planning, and establishment of appropriate manufacturing process validations and controls.
• Implement and provide on-going oversight to CAPA (corrective and preventive action), complaint handling, Non-conformance, Data Analysis, and Supplier Management Systems.

Our client is a designer and manufacturer of a variety of precision diagnostic and laser lenses. The product line includes slit lamps, digital direct and indirect contact laser lenses, surgery lenses and accessories. These products are marketed worldwide for use in medical, industrial and scientific applications.

Compensation
A competitive compensation package dependent upon the candidate’s experiences is offered for this position.

Willoughby, Ohio (approximately 24 miles northeast of Cleveland) - limited relocation assistance is available

Qualifications

• B.S. Degree in Engineering or related science with 3 to 5 years experience in Process Validation and Quality Engineering
• Quality management experience in a discreet manufacturing environment of precision products
• Good working knowledge of CAPA and complaint handling as they pertain to FDA inspections of device companies.
• Good working knowledge of Non-conformance, Data Analysis, and Supplier Management Systems
• Knowledge of quality systems, regulatory requirements and industry standards
• Must work independently, be a self starter, motivated, and work well under pressure
• Must be able to apply knowledge to day to day operations and search for process improvements
• Excellent written and oral skills
• Strong analytical skills and the ability to communicate with all levels of an organization
• Experience working within a formal quality management system (ISO/QS 9000) is highly desirable
• Specific skills or formal training in auditing, troubleshooting, problem solving, and/or lean manufacturing a definite plus