What are the responsibilities and job description for the Quality Systems Engineer position at TÜV SÜD?
Your Tasks
- Develop, implement, and maintain quality system processes to support day-to-day activities at the New Brighton facility.
- Ensure compliance with regulatory requirements including ISO 10993, ISO 17025, and 21 CFR Part 58.
- Organize and support customer, internal, and external audits.
- Troubleshoot analytical issues and collaborate with laboratory staff to ensure test robustness.
- Provide training and guidance to staff on quality system updates, data integrity, and documentation practices.
- Manage continuous improvement activities, including CAPAs, deviations, and investigations.
- Partner with global teams to collect, trend, and analyze data on process and control effectiveness.
Your Qualifications
- Bachelor's degree in Chemistry, Biological or Biomedical Engineering, or related scientific discipline.
- Minimum 2 years within an ISO 17025 accredited quality team, or 3–5 years in an accredited laboratory setting.
- Hands-on experience with chemical characterization, extractables/leachables, or biocompatibility testing preferred.
- Strong knowledge of ISO 10993 series, ISO 17025, GLP, and related regulatory requirements.
- Experience managing non-conformances, CAPAs, and risk management processes.
- Advanced problem-solving, analytical, and organizational skills with strict attention to detail.
- Excellent written and verbal communication skills; ability to collaborate across functions.
What We Offer
- Opportunity to work in a 20,000 sq. ft. medical device testing laboratory with global collaboration.
- Comprehensive training and professional development opportunities.
- Competitive compensation with bonus eligibility.
- 401(k) with employer match.
- 12 weeks of paid parental leave.
- Health, dental, and vision insurance, plus life and disability coverage.
- Generous paid time off.
Additional Information
- Domestic travel up to 10% and occasional international travel with advance notice.
- Role involves working in a laboratory environment with moderate noise and occasional lifting of up to 20 pounds.
- Onsite role based in New Brighton, MN.
Equal Employment Opportunity Statement
Equal Opportunity Employer – Disability and Veteran
TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.
For more information on applicable equal employment regulations, please refer to the following: Labor Law 2025.
Pay Transparency Statement
The anticipated annual base pay for this full-time position is
$75,000
. Actual base pay will be determined based on various factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target, subject to eligibility and other requirements. Additionally, we offer a comprehensive benefits package to employees, including a 401(k) plan with employer match, 12 weeks of paid parental leave, health plans (medical, dental, and vision), life insurance and disability, and generous paid time off.
Work Area: Others
Country/Region: United States
Job Location: New Brighton
Working Model : Onsite
Employment Type: Full time / regular
Company: TÜV SÜD America Inc.
Org Unit Code
Requisition ID: 1265
Salary : $75,000 - $120,000