At TÜV SÜD, technology drives everything we do. Every day, our work in testing, auditing, inspection, and advisory services helps shape a safer, smarter, and more sustainable world. We thrive on innovation, pursue excellence relentlessly, and take pride in leaving a lasting impact. If you’re inspired by progress and committed to quality, join us and help shape the future.
Your Responsibilities
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Develop and maintain quality system processes that support daily operations at the New Brighton facility.
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Ensure regulatory compliance with ISO 10993, ISO 17025, and 21 CFR Part 58 requirements.
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Plan and support customer, internal, and external quality audits.
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Investigate and troubleshoot analytical or process-related issues in collaboration with laboratory staff to ensure robust test performance.
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Train and guide employees on quality system updates, data integrity, and documentation best practices.
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Lead continuous improvement initiatives, including management of CAPAs, deviations, and investigations.
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Collaborate with global teams to collect, trend, and analyze data to monitor process control and quality system effectiveness.
Your Qualifications
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Bachelor’s degree in Chemistry, Biological or Biomedical Engineering, or a related scientific discipline.
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2+ years of experience within an ISO 17025–accredited quality organization, or 3–5 years in an accredited laboratory environment.
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Hands-on experience with chemical characterization, extractables/leachables, or biocompatibility testing preferred.
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Strong working knowledge of ISO 10993, ISO 17025, GLP, and other applicable regulatory frameworks.
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Proven ability to manage non-conformances, CAPAs, and risk management activities.
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Excellent problem-solving, analytical, and organizational skills with keen attention to detail.
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Clear and confident communication skills, with the ability to collaborate effectively across departments and global teams.
What We Offer
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Work in a state-of-the-art 20,000 sq. ft. medical device testing laboratory with global collaboration opportunities.
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Comprehensive training and professional development programs.
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Competitive compensation, including bonus eligibility.
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401(k) with employer match.
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12 weeks of paid parental leave.
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Full health, dental, and vision coverage, plus life and disability insurance.
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Generous paid time off and a supportive, mission-driven culture.