Quality Engineer I

Cordis • Irvine, CA

1h

About The Position

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. The mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. The Quality Engineer I will be responsible for ensuring that medical devices meet the highest quality standards throughout the process. The QE I will support the team through production scale up and associated quality deliverables. The primary focus will be ensuring that processes and products meet established quality standards through developing, implementing, and continuously improving quality management systems, ensuring compliance with regulations, standards, and customer requirements. The position will collaborate with cross-functional teams to help identify quality issues, drive process improvements, and champion a culture of quality excellence.

Requirements

• Bachelor’s degree in mechanical engineering, Biomedical or Industrial Engineering, or other related engineering fields.
• 2+ years in medical device production.
• Strong engineering background.
• Strong analytical and problem-solving skills.
• Strong communication skills.
• Excellent attention to detail and organizational skills.
• Ability to work collaboratively in a team environment.
• Fluent in English.
• US work authorization is a precondition of employment.

Nice To Haves

• Previous internship or co-op experience in quality assurance.
• Previous experience working in a clean room environment.

Responsibilities

• Monitor and implement quality control measures (including verification of materials, components, and finished products) at every stage of the process, ensuring compliance with regulatory standards and internal quality requirements.
• Continuously identify and implement process improvements to enhance product quality, reduce waste, and optimize efficiency.
• Work closely with R&D engineers to ensure design control is followed.
• Prepare risk assessment documentation related to processes and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices.
• Stay up to date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that processes adhere to these regulations.
• Participate in root cause analysis for quality issues and recommend / implement corrective actions.
• Assist in maintaining accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with company standards.
• Analyze process data and quality metrics to identify trends and areas for improvement.
• Provide quality support to sustaining current processes.
• Lead and support the implementation of revised Quality Systems (QS).
• Report on Quality Engineering activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 501-1,000 employees