Reliability Quality Engineer - Medical Device
Azzur Group CA is seeking a Reliability Engineer to support new product development projects at a medical device manufacturing site in the Los Angeles, CA area. The tasks performed will support engineering for equipment, catheters, and software. Additional duties may include documentation requirements/planning, component qualification, software validation, and safety requirements testing.
Essential Duties and Responsibilities
• Work to develop cross-functional teams to address concerns related to development and issues or with suppliers.
• Work cooperatively with External Operations, Sourcing, Partner Development and Engineering, Compliance, Category Teams, and others as required.
• Utilize PE methods and Quality Engineering practices to conduct/perform risk analysis, test method development, statistical data analysis, and statistical process control as well as conduct assessments at our suppliers.
• Execute technical skill specific to areas relating to materials, packaging, chemicals, etc.
• Perform FMEA, Non-conformances, CAPA, and other activities related to compliance and quality planning for products.
• Utilizing technical knowledge of processes and products, determine methods to improve technical assessment programs. Provide training to Junior Engineers.
• Develop protocols, procedures, test method validations and other documentation related to the product development process.
• BS Degree or equivalent in a Life Science, Engineering, or Physical Science
• Ten (10) years' experience in reliability engineering in the life sciences; new products development experience is a plus.
• Knowledge of mechanical drawings, electrical diagrams, and software architecture is required.
• Certified Quality Engineer/Certified Quality Auditor Certification (ASQ or equivalent) are preferred.
• Knowledge and experience with materials (plastic and metals), electronics, and software is preferred.
• Demonstrated experience managing others as well as fostering a team focused approach. The ideal candidate shall excel in the areas of communication, leadership, client loyalty, initiative and business integrity.
• Proficient in Process Excellence, Six Sigma, Lean methodologies or operational excellence. Six Sigma Green Belt or Black Belt certification is preferred.
• Applicant must demonstrate the ability to communicate to personnel across all levels of organization as well as be a detailed oriented, team player, and performance driven.
This position is located in Irwindale, CA, and may require up to 15% domestic and/or international travel. Only candidates currently living within a commutable distance to Irwindale, CA will be considered. This employer participates in E-Verify.
Azzur Core Values:
Puts Others First...Have the Courage to Take Action...Take Personal Responsibilities...Have Fun!
Azzur Group is a private company and comprised of several speciality companies Azzur Consulting, a GxP compliance and consulting organization dedicated to helping life sciences companies succeed. Our experienced staff specializes in manufacturing systems & equipment design, installation & startup, commissioning, and verification/qualification, computerized systems validation, process validation, project management and related functions. Azzur Consulting also offers GxP compliance and audit services related to regulatory inspection prep and inspectional finding remediation as well as general project management support. We are continuously updating and maintaining our knowledge base with the latest regulatory requirements, industry best practices, and inspectional trends to help our clients stay ahead.
Our team is a network of skilled problem solvers with broad experience across biotechnology, pharmaceuticals and medical device businesses. Our goal is to keep our clients at the top of their industry. After all, our success is determined by the success of our clients.
Los Angeles, CA
Tue, 4 Jul 2017 16:26:57 PDT