Sr. Quality Engineer
Irvine, CA
Schedule:
Standard Office Hours
Duration:
18-Month Contract
Pay:$51-56/hr (W2)
Our client is a leading global medical technology company specializing in innovative healthcare solutions. They are seeking a Sr. Quality Engineer to support R&D and Operations teams in design engineering, risk management, and regulatory compliance activities.
Essential Functions and Responsibilities
- Collaborate with 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
- Investigate moderately complex manufacturing product quality for all production processes based on engineering principles, analyze results, and make recommendations
- Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods for design for manufacturing and for continuous process improvement
- Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes and reduce risk
- Lead Risk Management process for project in compliance to appropriate external standards and corporate policies, to ensure critical to quality features are identified and addressed appropriately
- Create and maintain risk management documentation such as risk management worksheet and 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
- Mentor engineers in 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 successful achievement of company quality objectives
- Ensure 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, give instruction to engineers/technicians on conducting tests, train engineers/technicians and provide feedback, and may coordinate engineers/technician work
Education and Experience
- Bachelor's degree in engineering required
- 5-7 years experience required
Knowledge and Skills
- Basic leadership and mentoring skills necessary to provide support and constructive performance feedback
- Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports
- Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD)
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