Support label reconciliation, inspection, and documentation activities. * Verify label accuracy ... Knowledge of ISO 13485, FDA Quality System Regulation (21 CFR Part 820), or Good Manufacturing ...
Support label reconciliation, inspection, and documentation activities. * Verify label accuracy ... Knowledge of ISO 13485, FDA Quality System Regulation (21 CFR Part 820), or Good Manufacturing ...
Support label reconciliation, inspection, and documentation activities. * Verify label accuracy ... Knowledge of ISO 13485, FDA Quality System Regulation (21 CFR Part 820), or Good Manufacturing ...
Support label reconciliation, inspection, and documentation activities. * Verify label accuracy ... Knowledge of ISO 13485, FDA Quality System Regulation (21 CFR Part 820), or Good Manufacturing ...
Registered Dietician
Los Angeles, CA · On-site
$33.75 - $45.25/hr
... interns. · Creates in-service handouts, posters, and education materials regarding dietary ... the inspection of the food establishment. · Oversee the organization's compliance with FDA ...
Quick apply
Registered Dietician
Los Angeles, CA · On-site
$33.75 - $45.25/hr
... interns. · Creates in-service handouts, posters, and education materials regarding dietary ... the inspection of the food establishment. · Oversee the organization's compliance with FDA ...
Senior Director, Regulatory Affairs REMS Program
South San Francisco, CA · On-site
$263.88 - $307.86/hr
Support regulatory inspections and FDA audits related to REMS.# Management* May supervises employees, consultants/contractors, and/or interns in Regulatory Affairs* Mentors department personnel and ...
Senior Director, Regulatory Affairs REMS Program
South San Francisco, CA · On-site
$263.88 - $307.86/hr
Support regulatory inspections and FDA audits related to REMS.# Management* May supervises employees, consultants/contractors, and/or interns in Regulatory Affairs* Mentors department personnel and ...
Senior Director, Regulatory Affairs REMS Program
South San Francisco, CA · Hybrid
$263K - $307K/yr
Support regulatory inspections and FDA audits related to REMS. Management * May supervises employees, consultants/contractors, and/or interns in Regulatory Affairs * Mentors department personnel and ...
Senior Director, Regulatory Affairs REMS Program
South San Francisco, CA · Hybrid
$263K - $307K/yr
Support regulatory inspections and FDA audits related to REMS. Management * May supervises employees, consultants/contractors, and/or interns in Regulatory Affairs * Mentors department personnel and ...
Senior Director, Regulatory Affairs REMS Program
South San Francisco, CA · On-site
$263K - $307K/yr
Support regulatory inspections and FDA audits related to REMS. Management * May supervises employees, consultants/contractors, and/or interns in Regulatory Affairs * Mentors department personnel and ...
Senior Director, Regulatory Affairs REMS Program
South San Francisco, CA · On-site
$263K - $307K/yr
Support regulatory inspections and FDA audits related to REMS. Management * May supervises employees, consultants/contractors, and/or interns in Regulatory Affairs * Mentors department personnel and ...
Cybersecurity Quality Engineer
$85K - $105K/yr
Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, FDA cybersecurity guidance, or related ... inspections, audits, and cross-functional collaboration. * Occasional lifting and carrying of ...
Cybersecurity Quality Engineer
$85K - $105K/yr
Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, FDA cybersecurity guidance, or related ... inspections, audits, and cross-functional collaboration. * Occasional lifting and carrying of ...
Cybersecurity Quality Engineer
Irvine, CA · On-site
$85K - $105K/yr
Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, FDA cybersecurity guidance, or related ... inspections, audits, and cross-functional collaboration. * Occasional lifting and carrying of ...
Cybersecurity Quality Engineer
Irvine, CA · On-site
$85K - $105K/yr
Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, FDA cybersecurity guidance, or related ... inspections, audits, and cross-functional collaboration. * Occasional lifting and carrying of ...
Sr. Quality Systems & Compliance Engineer
$137K - $188K/yr
Support site audits, inspection readiness activities, and resolution of quality system issues ... Experience hosting FDA, Notified Body, MDSAP, or ISO 13485 audits. * Experience with electronic ...
Quick apply
Sr. Quality Systems & Compliance Engineer
$137K - $188K/yr
Support site audits, inspection readiness activities, and resolution of quality system issues ... Experience hosting FDA, Notified Body, MDSAP, or ISO 13485 audits. * Experience with electronic ...
Support site audits, inspection readiness activities, and resolution of quality system issues ... Experience hosting FDA, Notified Body, MDSAP, or ISO 13485 audits. * Experience with electronic ...
Support site audits, inspection readiness activities, and resolution of quality system issues ... Experience hosting FDA, Notified Body, MDSAP, or ISO 13485 audits. * Experience with electronic ...
Sr. Quality Systems & Compliance Engineer
San Jose, CA · On-site
$137K - $188K/yr
Support site audits, inspection readiness activities, and resolution of quality system issues ... Experience hosting FDA, Notified Body, MDSAP, or ISO 13485 audits. * Experience with electronic ...
Sr. Quality Systems & Compliance Engineer
San Jose, CA · On-site
$137K - $188K/yr
Support site audits, inspection readiness activities, and resolution of quality system issues ... Experience hosting FDA, Notified Body, MDSAP, or ISO 13485 audits. * Experience with electronic ...
Internship Fda Inspector information
$24/hr
Full-time
Posted 12 days ago
Job description
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 Operations Intern will support daily activities within the Labeling Process and Formulation Laboratory to ensure manufacturing operations comply with quality standards, regulatory requirements, and production schedules. This 6-month internship provides hands-on exposure to medical device manufacturing, documentation practices, quality systems, and laboratory operations in a regulated environment.
Key Responsibilities
Labeling Process
- Assist with the preparation, verification, and issuance of product labels in accordance with approved procedures and regulatory requirements.
- Support label reconciliation, inspection, and documentation activities.
- Verify label accuracy, including product information, lot numbers, expiration dates, and barcode readability.
- Participate in label change control and document revision processes.
- Help maintain compliance with Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
Formulation Laboratory
- Assist laboratory personnel in preparing formulations, solutions, and materials according to established procedures.
- Support laboratory testing, sample preparation, and data collection activities.
- Maintain laboratory equipment cleanliness, calibration records, and inventory of chemicals and consumables.
- Record experimental observations and maintain accurate laboratory documentation.
- Follow laboratory safety protocols and Good Laboratory Practices (GLP).
Operations Support
- Support production documentation, and quality records.
- Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Engineering teams.
- Perform other operational and administrative duties as assigned.
Qualifications
Required Qualifications
- Currently pursuing a bachelor's degree in a related scientific discipline.
- Strong interest in medical device manufacturing and regulated industries.
- Basic understanding of laboratory practices and manufacturing operations.
- Familiarity with Microsoft Office Suite (Excel, Word, PowerPoint).
- Excellent organizational, analytical, and communication skills.
- Ability to work independently and collaboratively in a team environment.
- High attention to detail and commitment to quality and compliance.
Preferred Qualifications
- Knowledge of ISO 13485, FDA Quality System Regulation (21 CFR Part 820), or Good Manufacturing Practices (GMP).
- Experience with laboratory techniques or manufacturing environments through coursework or previous internships.
- Exposure to Lean Manufacturing or Six Sigma concepts is an advantage.
Learning Outcomes
By the end of the internship, the intern will gain experience in:
- Medical device manufacturing operations
- Labeling compliance and documentation control
- Formulation laboratory procedures
- Quality Management Systems (QMS)
- Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
- Cross-functional collaboration within a regulated medical device environment
- Continuous improvement and operational excellence principles
This description reflects responsibilities commonly assigned to operations interns in FDA- and ISO-regulated medical device manufacturing environments while providing meaningful exposure to both production labeling and laboratory processes
Pay / Compensation - The expected pre-tax pay rate for this position is $24 hourly
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.
About Cordis
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
1,001 - 5,000 Employees
Headquarters location
Miami Lakes, FL, US
Year founded
1957