Overview
Senior Quality Engineer Jobs in Irvine, CA at Cynet Systems
Title: Senior Quality Engineer
Company: Cynet Systems
Location: Irvine, CA
Job Overview
Pay Range: $54.18hr – $59.18hr
Responsibilities
- Perform quality engineering activities supporting product development and cleanroom build operations.
- Ensure New Product Development (NPD) processes comply with quality systems and applicable regulatory standards.
- Update and maintain risk management and design control documentation.
- Develop and execute test method validations and qualification plans.
- Support design verification, process validation, and commercialization activities, including multi-site transfers.
- Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory, Clinical, and Marketing.
- Maintain accurate and compliant quality documentation aligned with internal and external standards.
- Contribute to continuous improvement initiatives and quality assurance processes.
- Perform additional duties as assigned by leadership.
Qualifications
- Bachelor s degree in Engineering or a Scientific field with 4+ years of experience, OR
- Master s degree (or equivalent) in Engineering or a Scientific field with 3+ years of experience.
- Strong understanding of engineering and quality principles, theories, and concepts.
- Experience in product development, quality assurance, or related fields.
- Knowledge of ISO 13485 standards.
- Experience maintaining risk management files and design control documentation.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills with strong attention to detail.
- Ability to manage multiple priorities in a fast-paced environment.
Preferred Qualifications
- Experience in medical device manufacturing or operations.
- Hands-on experience with test method development, validation, and fixture development.
- Basic understanding of statistical techniques and experience with tools such as Minitab.
- Ability to build strong cross-functional relationships and work collaboratively across teams.
Skills And Competencies
- Strong organizational and documentation skills.
- Attention to detail with a focus on quality and compliance.
- Effective stakeholder communication and teamwork.
- Ability to handle competing priorities and deliver results under pressure.
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading staffing and recruiting powerhouse. Proudly recognized as a nationally and locally certified diversity firm, Cynet delivers agile, scalable talent solutions across industries. With an active footprint in all 50 U.S. states and Canada, we support thousands of consultants through our expansive, high-performing recruitment engine operating across North America and Asia ensuring speed, quality, and consistency in every hire.
