Austin, Texas, United States
IDR is seeking a Quality Systems Engineer III to join one of our top clients for an opportunity in Austin, TX. This role involves supporting the development and maintenance of the Quality Management System within a medical device manufacturing environment. The company is committed to innovation and regulatory compliance in healthcare technology through robust quality processes.
Position Overview for the Quality Systems Engineer III:
- Ensure compliance with global medical device regulations such as FDA 21 CFR Part 820, ISO 13485, and EU MDR.
- Support the harmonization and continuous improvement of the local Quality Management System (QMS).
- Collaborate with cross-functional teams to update and implement procedures ensuring regulatory compliance.
- Assist with gap assessments and align procedures to corporate and regulatory requirements.
- Drive quality initiatives and support process validation and risk management activities.
Requirements for the Quality Systems Engineer III:
- Extensive knowledge of global regulatory requirements for medical devices, including: 21 CFR Part 820 ISO 13485 EU MDR ISO 14971.
- Skilled in developing and implementing procedures for various QMS elements including but not limited to: Purchasing controls, Design controls, Nonconformance management, Validation, Corrective and Preventive Actions (CAPA).
- Familiarity with quality tools and methodologies, including: Six Sigma, Root cause analysis, Risk management, Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA).
- Strong communication and collaboration skills with the ability to influence and drive alignment across diverse stakeholders (including R&D and Regulatory).
- Must have previous Medical Device experience.
What's in it for you?
- Competitive compensation package
- Full Benefits; Medical, Vision, Dental, and more!
- Opportunity to get in with an industry leading organization.
Why IDR?
- 25+ Years of Proven Industry Experience in 4 major markets
- Employee Stock Ownership Program
- Dedicated Engagement Manager who is committed to you and your success.
- Medical, Dental, Vision, and Life Insurance
- ClearlyRated's Best of Staffing® Client and Talent Award winner 12 years in a row.
