QA/RA Specialist
About the role
You will work with the FDA and international regulatory bodies on product submissions, audits, and event reporting. You will participate in cross-functional teams for new product development and changes to existing products to ensure regulatory compliance. You will also be part of the team that maintains the quality management system.
Responsibilities
- Ensure product/process compliance with the US and international requirements
- Work with Engineering on new product releases and changes to develop Regulatory Plans
- Work with Design and Development Project teams to ensure compliance with Design Control Requirements
- Work with the FDA on product submissions
- Initiate US and International product submissions and registrations
- Participate in internal and external audits
- Reporting of adverse events to FDA
- Other duties as assigned
Requirements
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Qualifications
- Bachelor’s degree from a four-year college or university, preferably an engineering or technical degree or equivalent work experience
- Good communication skills at all levels (written and verbal)
- Ability to plan and manage multiple tasks/projects
Skills
- None required for this position
Benefits
N/A
Pay
N/A
Schedule
N/A
Supervisory Responsibility
This position has no supervisory responsibilities
Physical Demands
This is largely a sedentary role; however, some activity is required. This would require the ability to lift, bend or stand as necessary.
Travel
This position requires up to 10% travel. Some of the travel may be international.
Additional Eligibility Qualifications
N/A
Equal Opportunity Employer
CAIRE is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.