Quality System Engineer

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500 employees globally, with over 30 locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

Company: One of Our Clients

Job Description:

Title: Quality Systems Engineer III

Duration: 08 months contract (Extendable)

Location: Austin, TX 78744

Pay Rate: $45.00 – 48.86/hr on W2

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.

What You Can Expect How You'll Create Impact 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.
• This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Skills:

What Makes You Stand Out Expected Areas of Competence (i.e., knowledge, skills and abilities)

• 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.

Awards and Accolades:

America's Most Honored Businesses (Top 10%)

Awarded by USPAAC for the Fastest Growing Business in the US

12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)

Fastest 50 by NJ Biz (2020, 2019, 2020)

INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)

Top 100 by Dallas Business Journal (2020 and 2019)

Proven Supplier of the Year by Workforce Logiq (2020 and 2019)

2019 Spirit of Alliance Award by Agile1

2018 Best of the Best Platinum Award by Agile1

2018 TechServe Alliance Excellence Awards Winner

2017 Best of the Best Gold Award by Agile1(Act1 Group)