Job Title: Quality Engineer (Medical Devices)

Must be able to work on a W2

Job Summary:

We are seeking a dedicated and detail-oriented Quality Engineer to join our team in the medical device industry. The successful candidate will be responsible for ensuring that our products meet all required quality standards and regulatory requirements. You will play a key role in the design, development, and implementation of quality systems and processes. This position requires a strong background in quality engineering, excellent problem-solving skills, and a commitment to continuous improvement.

Job Duties:

• Develop, implement, and maintain quality assurance protocols and procedures to ensure compliance with regulatory standards and company policies.
• Conduct root cause analysis and corrective action investigations to resolve product and process non-conformances.
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality requirements are integrated into product development and production processes.
• Perform internal audits and support external audits to ensure compliance with ISO 13485, FDA regulations, and other relevant standards.
• Analyze quality data and metrics to identify trends and areas for improvement, and implement effective solutions to enhance product quality and reliability.
• Assist in the development and review of quality documentation, including standard operating procedures, work instructions, and inspection plans.

Job Qualifications:

• Bachelor’s degree in Engineering, Quality Assurance, or a related field.
• Minimum of 5 years of experience in quality engineering, preferably in the medical device industry.
• In-depth knowledge of ISO 13485, FDA regulations, and other relevant quality standards.
• Strong analytical and problem-solving skills, with the ability to conduct root cause analysis and implement effective corrective actions.
• Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
• Certification in Quality Engineering (CQE) or other relevant certifications is a plus.

Term and start

• Contract role
• Pay rate: Determined by experience
• Location: Temecula, CA