Quality Manufacturing Engineer

Cordis; Irvine (CA); On-site; USD 68,200 - 84,700; Full time

Job summary

Cordis in Irvine, CA is seeking a Quality Engineer I to ensure medical devices meet quality standards throughout production and scale-up. You will support cross-functional teams to improve processes, implement quality management systems, and maintain documentation to regulatory requirements.

Responsibilities include quality control, process improvement, design control with R&D, risk assessment, regulatory compliance, root cause analysis, data analysis of quality metrics, and ensuring

Qualifications

• Bachelor’s degree in mechanical engineering, biomedical or industrial engineering, or other related engineering fields.
• 2+ years in medical device production or QA internship/co-op experience in quality assurance.
• Previous experience in a clean room environment preferred.
• Strong engineering background.
• Strong analytical and problem-solving skills.
• Strong communication and organizational skills.
• Fluent in English.

Responsibilities

• Quality Control: Monitor and implement quality control measures at every stage to meet regulatory standards and internal requirements.
• Process Improvement: Identify and implement process improvements to enhance product quality and efficiency.
• Design control: Collaborate with R&D to ensure design control is followed.
• Risk Assessment: Prepare risk assessment documentation and identify mitigation opportunities.
• Regulatory Compliance: Stay updated with medical device regulations and standards.
• Root Cause Analysis: Participate in root cause analysis and implement corrective actions.
• Documentation: Maintain accurate documentation of quality-related processes, inspections and testing.
• Data Analysis: Analyze process data and quality metrics to identify trends and areas for improvement.

Skills

Analytical skills

Communication skills

Teamwork

Attention to detail

English fluency

Education

Bachelor's degree in Mechanical Engineering

Job description

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.

Responsibilities

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.

Strategic Impact

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

Key Interactions

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

Qualifications

Required Skills and Experience

• 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

Physical Requirements

• 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.

Pay / Compensation

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.

Preferred Qualifications

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.

Job Locations

US-CA-Irvine

Position Type

Regular Full-Time

CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact [e-mail]