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Quality Systems Engineer III
Net2Source
- 🇺🇸 United States
- On-site
- 1 day ago
- $40 – $50 / hour
- Risk Management
- IEC
- CAPA
- Six Sigma
- SPC
- FMEA
- ERP
- SAP
- Regulatory Compliance
1 day ago
Who We Are
Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price.
Job Title: Quality Systems Engineer III
Location: Austin, TX 78744
Duration: 04+ Months (Extendable until Dec 2027)
ID:37762659
Client: Medical Device
Pay Rate: $40.00 – 50.00/hr on W2
Note from Client:
- Looking for someone who really knows regulatory requirements inside and out for medical devices Both hardware and software preferred (SaMD - Software as a Medical Device).
- Some experiences that would make someone stand out - Prior experience with QMS harmonization and/or remediation, owning a QMS and the relevant procedures for a site or process, Audit experience, also as the site is primarily design focused prior experience with design controls and risk management.
- Again, not expecting someone to have all of these on their resume, but they should have some degree of experience in these areas.
Job description:
- Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS).
- The position is responsible for supporting the global development, implementation, and continuous improvement and harmonization of the local Quality Management System (QMS) in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR as well as corporate procedures and requirements.
Principal Duties and Responsibilities:
- Support cross-functional teams in the harmonization and standardization of quality procedures, tools, and best practices across sites and regions.
- Complete gap assessments for local procedures against corporate procedures, requirements and applicable medical device regulations and standards.
- Collaborate with cross functional team members to align & execute updates to local procedures to align with applicable requirements.
Skills:
• Extensive knowledge of global regulatory requirements for medical devices, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.
• Skilled in developing and implementing procedures for various QMS elements including but not limited to purchasing controls, design controls, nonconformance management, validation, and corrective and preventive actions (CAPA).
• Familiarity with quality tools and methodologies (e.g., Six Sigma, root cause analysis, risk management, SPC, FMEA).
• Strong communication and collaboration skills, with the ability to influence and drive alignment across diverse stakeholders (R&D and Regulatory).
• Preferred experience with enterprise quality systems and ERP systems (e.g., SAP, EtQ).
• Must have previous Medical Device Experience
• Preferred experience with SaMD (Software as a medical device) and class II medical devices.
Education:
Your Background Education/Experience Requirements
• High school diploma or equivalent required.
• Bachelor's degree in Engineering preferred.
• Technical, engineering, and/or scientific background is strongly preferred.
• Minimum 5+ years of experience in Quality/Regulatory Compliance or related field required
• CQE or equivalent certification preferred.
• Must be familiar with Microsoft Office Suite.
About Net2Source, Inc.
Net2Source is an employer-of-choice for over 2200+ consultants across the globe. We recruit top-notch talent for over 40 Fortune and Government clients coast-to-coast across the U.S. We are one of the fastest-growing companies in the U.S. and this may be your opportunity to join us!
Why Work With Us?
We believe in more than just jobs—we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter.
Our Commitment to Inclusion & Equity
Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics.
Quality Systems Engineer III · Net2Source