Demo

Lead Tech Quality Control, Selution

Cordis
Irvine, CA Full Time
POSTED ON 2/8/2025
AVAILABLE BEFORE 3/9/2025
Overview

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.

Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.

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.

Reporting to Q.C. Technical Management, the Quality Control (QC) Technician Lead is responsible for coordinating the work of other QC Technicians and assuring working is performed in support of the production team’s needs while supporting MedAlliance’s Quality Policy. The position includes reviewing, inspecting, dispositioning, approving, and releasing raw material, all labeling, and finished product lots. In addition, the Q.C. Technician Lead will be assigned other duties as directed by Quality Assurance (Q.A) Management. In addition, the position will also serve as a back-up for second shift support, when required.

Responsibilities


  • Lead a team of quality control inspectors in various workspaces for Receiving Inspection, Label Inspection and Final Product Release, ensuring team members are informed and following the quality instructions. Ensure GMP’s, GDP’s and any safety requirements are followed.
  • QC Technician Lead will also perform duties in support of the team:
  • a) Inspecting and disposition of raw materials and labels
  • b) Reviewing of work order documentation prior to product release
  • c) Preparing non-conforming documents for material disposition as needed
  • d) Preparing release documentation and appropriate traceability labeling for incoming materials and product release
  • Additional roles include:
  • a) Coordinating HPLC Testing with Q.A. Chemistry Team
  • b) Pro-active review and revise of Quality relevant procedures (Q.I.s, RIRs, W.I)and coordinate with technical management to ensure compliance.
  • c) Completing other duties as assigned.
  • d) Coordinating and facilitating Non-conformances meeting
  • e) Initiating and following up on NCs using various monitoring tools related to Receiving inspections and final release
  • f) Provide updates to management and stakeholders
  • g) Proactively manage the upcoming challenges and issues and coordinate with stakeholders to identify the path forward
  • h) support management in resource management


Qualifications


  • High School or equivalent education.
  • Preferable 2 years of experience in a medical device or other regulated manufacturing industry in a Q.C. lead or back-up lead capacity.
  • Internal candidates must have a minimum tenure of 1 year in the current position.


Competencies & SkillsMust have an understanding of good manufacturing and good documentation practices


  • Strong interpersonal skills, and good problem-solving abilities
  • Ability to read, comprehend and follow written procedures.
  • Ability to Understand and follow verbal instructions.
  • Computer skills using Microsoft applications (Outlook, Word, Excel) and other computer software packages.
  • Fluent in English
  • Ability to communicate ideas, problems and solutions to quality supervisor or management.
  • Ability to lead a team
  • Ability to work overtime and/or weekends, according to business need


Pay / Compensation

The expected pre-tax pay rate for this position is $xx.xx - $xx.xx 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.

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