QC Technician - Medical Device

Cordis; Irvine (CA); On-site; USD 28,419 - 35,335; Full time

Job summary

Cordis is hiring for a Quality Control/Manufacturing support role in Irvine, CA. The incumbent will inspect materials, review documentation, and prepare release and traceability labeling for incoming materials and product release.

They will also provide QC approvals in the clean room and coordinate HPLC testing with QA Chemistry. Applicants should have a high school diploma or equivalent and at least one year in a regulated manufacturing setting; familiarity with GMP and good documentation

Qualifications

• Requires a high school diploma or equivalent.
• 1 year of experience in a medical device or regulated manufacturing setting preferred.
• Strong attention to detail with the ability to identify discrepancies.
• Basic understanding of good manufacturing and good documentation practices.
• Proficient with Microsoft Office (Outlook, Word, Excel) and related software.

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.
• Coordinate HPLC testing with QA Chemistry Team.
• Review SOPs, QIs, RIRs, and component specifications.

Skills

Attention to detail

GMP knowledge

Overtime availability

Second shift backup

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
• Proactive 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

Pay / Compensation

The expected pre-tax pay rate for this position is $20.63 – 25.65 hourly. 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.