Quality Control Technician - Medical Device (Second Shift)

Cordis; Irvine (CA); On-site; USD 28,000 - 35,000; Full time

Job summary

Cordis in Irvine, CA, seeks a detail-oriented materials QC/designer to inspect and disposition raw materials, review documentation before release, and prepare release and traceability labeling for materials and products. You will support GMP and QA processes in a clean room environment.

Responsibilities include coordinating HPLC testing with QA Chemistry, maintaining non-conformity records, and ensuring adherence to SOPs and specifications. Weekend/overtime availability may be required.

Qualifications

• High School diploma or equivalent required.
• 1+ year of experience in a medical device or regulated manufacturing environment preferred.
• Attention to detail with ability to identify discrepancies.
• Basic understanding of good manufacturing and good documentation practices.
• Computer skills: Outlook, Word, Excel.
• Ability to work overtime and/or weekends as needed.
• Ability to back-up for second shift if required.
• Ability to lift 10–20 pounds.

Responsibilities

• Inspect and disposition of raw materials and labels.
• Review work order documentation prior to product release.
• Prepare non-conformity documentation for material disposition as needed.
• Prepare release documentation and traceability labeling for incoming materials and product release.
• Provide QC approvals of selected processes in the clean room manufacturing environment.
• Complete other duties as assigned.
• Coordinate HPLC testing with QA Chemistry Team.
• Pro-active review of SOPs, QIs, RIRs, and Component Specifications.

Skills

Attention to detail

Good documentation practices

Microsoft Office

Education

High School diploma or equivalent

Tools

Microsoft Office

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

• Inspecting and disposition of raw materials and labels
• Reviewing of work order documentation prior to product release
• Preparing non-conformity documentation for material disposition as needed
• Preparing release documentation and appropriate traceability labeling for incoming materials and product release
• Providing QC approvals of selected processes in the clean room manufacturing environment.
• Completing other duties as assigned.
• Coordinating HPLC Testing with QA Chemistry Team
• Pro-active review of Quality relevant procedures (SOPs, Q.I.s, RIRs, and Component Specifications
• Completing other duties as assigned.

Qualifications

• High School diploma or equivalent education require
• 1+ year of experience in a medical device or other regulated manufacturing industry, preferred.
• Attention to detail and focus allowing for the identification of discrepancies or anomalies
• Basic understanding of good manufacturing and good documentation practices
• Computer skills using Microsoft applications (Outlook, Word, Excel) and other computer software packages.
• Ability to work overtime and/or weekends, according to business needs
• Ability to be a back-up for second shift support, if needed
• Ability to lift 10-20 pounds

At Cordis, we’re teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients. If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives.

Pay / Compensation

The expected pre-tax pay rate for this position is $20.62 - $25.65 per hour

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 teammate’s 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.