Quality Systems Engineer

job summary:

Our Client is seeking a Quality Systems Engineer in Austin, TX (hybrid). Need 5+ yrs medical device QMS/regulatory experience. Join Our Client, a medical tech leader pushing the boundaries of innovation to redefine the patient healthcare journey and transform global mobility!

location: Austin, Texas

job type: Contract

salary: $45.33 - 52.12 per hour

work hours: 8am to 5pm

education: High School

responsibilities:

• Lead the implementation and continuous improvement of the Quality Management System (QMS) in compliance with global medical device regulations like FDA 21 CFR Part 820, ISO 13485, and EU MDR.
• Support cross-functional teams in harmonizing and standardizing quality procedures, tools, and best practices across global sites and regions.
• Conduct comprehensive gap assessments of local procedures against the corporate procedures and regulatory standards of Our Client.
• Collaborate with diverse stakeholders, including R&D and Regulatory teams, to align and execute updates to local procedures and drive organizational compliance.

qualifications:

• Experience level: Experienced
• Education: High School

skills:

• Quality
• Validation
• Medical Device

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 HRsupport@randstadusa.com.

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.