Quality Systems Engineer
Job ID: 491999 Posted 1 day ago
Austin, Texas
Contract
Systems Engineering
Job Details
To Apply for this Job Click Here
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.
To Apply for this Job Click Here
I want more jobs like this in my inbox.
Share This Job
Similar Jobs
Irving, Texas
Contract to Hire
Systems Engineering
Denver, Colorado
Contract
Systems Engineering
60-70
New York, New York
Contract
Systems Engineering
Why Us?
IDR has been in business for over 25 years and offers access to hundreds of companies across the country to work for. For many of the contractors that work for us, there are some unique benefits to being a part of the IDR team. One specific benefit is that we believe our contractors are part of something bigger than yourself. We are an employee-owned company and in an ESOP (Employee Stock Ownership Plan), as the share price of our company grows, so does your equity in our company. Our contractors, as well as our internal employees, can participate in this plan after one year of service. In addition to joining our ESOP program, you will also receive weekly pay, 401k access, and access to three different benefit plans that cover 50% of the individual premiums along with access to unlimited behavioral health sessions with a licensed counselor.
About Us
IDR, Inc. is an award-winning, employee-owned staffing firm with headquarters in Alpharetta, GA and offices in the Nashville, Dallas, and Denver markets. Founded in 1998, IDR has grown to serve businesses and professionals across industries including IT, healthcare, accounting and finance, government services, and professional services. Recognized for our expertise and the high-touch approach of our Engagement Management Program, IDR continues to build rewarding partnerships with companies and consultants. Our best-in-class service has earned IDR ClearlyRated’s Best of Staffing Client and Talent awards for ten consecutive years, in addition to awards from Staffing Industry Analysts and Best and Brightest Companies to Work For. With our commitment to empowering talent and developing leaders, we’re passionate about what we do and how we do it, and we look forward to working with you.