Quality Engineer (Design Verification)

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Job Title: Quality Engineer (Design Control) Pay Rate: $60 to $65.67/HR Duration: 18 months Location: Irvine, CA (Onsite)

Our Client is a Global medical device Manufacturer.

We are looking for a Quality Engineer (Design Control) whowill collaborate with a cross-functional design team to develop novel cardiovascular devices/therapies, providing quality leadership and vision throughout the initial product development cycle up to commercialization, while ensuring compliance to applicable internal and external requirements. In this position, the engineer will work closely with R&D to define strategy, as well as refine and finalize the design per the NPD process. In addition, the engineer will work with the Operations team to help facilitate the successful transfer/launching of robust products. This position provides an opportunity to work in a fast-paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.

• Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management , Design Controls , Design Verification , Statistical Techniques, Test Method Development , Process Development, Quality Assurance, and Regulatory Compliance.
• Lead the Risk Management process for project in compliance to the appropriate external standards and corporate policies, to ensure critical to quality features are identified and addressed appropriately.
• Responsible for creating and maintaining risk management documentation such as risk management worksheet, FMEAs, in alignment with ISO:14971
• Provide integral technical input for the development of project plans, project timelines, and strategy to support premarket approval of products.
• Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities.
• Strong leadership and collaboration with other leaders in the project and across the organization
• Mentor engineers in the understanding of quality systems and strategies within new product development.
• Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.)
• Support resolution of manufacturing and compliance issues (i.e., CAPA, non-conformances, audit observations, etc.) utilizing problem-solving tools.
• Support Quality Engineering activities to improve customer satisfaction and the successful achievement of company quality objectives.
• Responsible for ensuring compliance with all National/Federal, local, and company regulations, policies, and procedures.
• Train, coach, and guide lower-level employees on more complex procedures
• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/technicians' work.

Skills:

• In-depth knowledge of Design Control, Risk Management , and related standards, as applicable for medical devices.
• Knowledge of Quality Engineering and Six Sigma concepts, with the ability to apply to work products
• Strong technical and analytical engineering skills. Able to understand drawings and device design at a practical level.
• Excellent verbal and written communication skills. Able to communicate clearly and concisely yet thoroughly.
• Strong leadership skills and the ability to influence change
• Ability to handle multiple tasks simultaneously.
• Must be accurate in handling detailed information/data.
• Experience in early human use of NPD strongly preferred.
• Experience in Design for Manufacturing (DFM) preferred.
• Certified Six Sigma Black belt / CQE preferred.
• Experience with electronic devices, data transmission/acquisition, a plus.

Must-have skills :

• Design control in medical devices
• NPD Quality Assurance
• Risk Management

Requirements:

• Bachelor's Degree or equivalent in Engineering with 4 years of related industry experience OR
• Master's Degree in Engineering with 3 years of related industry experience
• NPD experience as Quality/Design Assurance in Early Human Use, ISO 13485, ISO 14971.
• Experience in early medical device development as Design Assurance/Quality Engineer, result drive, flexible and critical thinking.

Job Type: Contract

Pay: $60.00 - $65.67 per hour

Schedule:

• 8 hour shift

Work Location: In person