Quality systems engineer

job summary:
Join Our Client as a Quality Systems Engineer a medical tech leader redefining patient care! Bring your 5+ years of QMS experience and global regulatory knowledge to a dynamic team pushing the boundaries of innovation.

location: Austin, Texas
job type: Contract
salary: $43 - 56 per hour
work hours: 8am to 5pm
education: Bachelors


responsibilities:

• Drive the continuous improvement, implementation, and global harmonization of the Quality Management System (QMS).
• Ensure strict compliance with medical device regulations, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, and EU MDR.
• Partner with cross-functional teams to standardize quality procedures, tools, and best practices across multiple sites and regions.
• Execute gap assessments to align local procedures with corporate requirements and global regulatory standards.
• Develop and implement essential QMS elements, including design controls, CAPA, purchasing controls, and nonconformance management.

qualifications:
Minimum of 5+ years of experience in Quality or Regulatory Compliance within the medical device industry.

Bachelor's degree in Engineering or a related technical/scientific field strongly preferred.

Extensive knowledge of global regulatory standards (21 CFR Part 820, ISO 13485, EU MDR, ISO 14971) and QMS methodologies; CQE certification and SaMD experience preferred.

skills:
FMEA,Microsoft Office Suite,SAP,SPC,communication,ability to influence,corrective and preventive actions,CAPA,design controls,ERP systems,ISO 13485,ISO 14971,purchasing,EU MDR,medical devices,collaboration skills,QMS,quality systems,Regulatory Compliance,regulatory requirements,R&D,risk management,root cause analysis,Six Sigma

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on click.appcast.io.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.