Quality Engineer

Overview

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. Our 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 our medical devices meet the highest quality standards throughout the process. The QE I will be responsible for supporting the team through production scale up and associated quality deliverables. The primary focus will be ensuring that our 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.

• Quality Control:
  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.
• Process Improvement:
  Continuously identify and implement process improvements to enhance product quality, reduce waste, and optimize efficiency.
• Design control:
  Work closely with R&D engineers to ensure design control is followed.
• Risk Assessment:
  Prepare risk assessment documentation related to processes and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices.
• Regulatory Compliance:
  Stay up to date with regulatory requirements, standards, and guidelines relevant to the medical device industry and ensure that processes adhere to these regulations.
• Root Cause Analysis:
  Participate in root cause analysis for quality issues and recommend/implement corrective actions.
• Documentation:
  Assist in maintaining accurate and complete documentation of quality-related processes, inspections, and testing, ensuring compliance with company standards.
• Data Analysis:
  Analyze process data and quality metrics to identify trends and areas for improvement.

• Quality support to sustaining current process.
• Quality leads to support and implementation of revised QS

• Report on Quality Engineering.
• Potential to interact with all functions including suppliers and customers depending on the topic/project being led or supported.

• Bachelor’s degree in mechanical engineering, Biomedical or Industrial Engineering, or other related engineering fields.
• 2+ years in medical device production or previous internship or co-op experience in quality assurance or is a plus.
• Previous experience working in a clean room environment [preferred]
• 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

• Light office work and telecommuting capability.
• Available to travel 20% of the time, as required domestic and international.
• Must be able to lift and carry up to 50 lbs.

The expected pre-tax pay rate for this position is $68,200 - $84,700. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity.

All our teammates’ points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.

US-CA-Irvine