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Quality Engineer III- #26-22455
Job Location:
Job Location:
Saint Paul, MN - USA
Hourly Salary:
USD 65 - 67
Hourly Salary:
Posted:
10 September 2026 (Yesterday)
Posted:
Application Deadline:
8 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Duration: 12 months
Summary:
The Preclinical Laboratory Quality Engineer provides quality support for preclinical testing laboratories suppliers and studies worldwide to determine compliance with established internal and external requirements including ISOCFR 820 21 CFR 58 ISO 10993 and ISO/IEC 17025 as applicable. This role evaluates quality system effectiveness supports inspection readiness and contributes to the Preclinical Corrective and Preventive Action (CAPA) program.
This position serves as Quality Assurance or Quality Engineer as applicable for internal procedures and preclinical laboratory studies and conducts internal and external quality reviews to ensure compliance with regulatory requirements and company policies.
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions please visit .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race colour religion sex sexual orientation gender identity national origin disability or status as a protected veteran.
AI Statement: By applying you acknowledge that AI-assisted tools may be used during hiring.
#LI-AS140
Summary:
The Preclinical Laboratory Quality Engineer provides quality support for preclinical testing laboratories suppliers and studies worldwide to determine compliance with established internal and external requirements including ISOCFR 820 21 CFR 58 ISO 10993 and ISO/IEC 17025 as applicable. This role evaluates quality system effectiveness supports inspection readiness and contributes to the Preclinical Corrective and Preventive Action (CAPA) program.
This position serves as Quality Assurance or Quality Engineer as applicable for internal procedures and preclinical laboratory studies and conducts internal and external quality reviews to ensure compliance with regulatory requirements and company policies.
Responsibilities will include:
- Support laboratory functions to maintain compliance with applicable regulations and standards validated methods and internal policies procedures and work instructions while promoting continuous inspection readiness.
- Collaborate with quality management and laboratory management on process improvement initiatives quality trends and continuous improvement projects.
- Conduct internal and external quality assurance audits of systems testing laboratories procedures and controls used in testing activities under applicable regulations and standards.
- Plan schedule and conduct vendor audits.
- Partner with global preclinical teams and Strategic Sourcing regarding new vendor requests and ongoing vendor needs.
- Evaluate the adequacy and compliance of systems operations and practices through facility- and process-based audits and quality monitoring activities.
- Assess the accuracy validity and overall quality of preclinical study data.
- Communicate final results of quality reviews and audits to management and technical staff.
- Write and publish audit and quality review reports obtain appropriate approvals and distribute findings to responsible stakeholders.
- Oversee follow-up of corrections and corrective actions escalate overdue items and support timely closure.
- Support or lead assigned quality projects and initiatives.
- Track audits and responses support document review activities and maintain appropriate records.
- Contribute to the development and continuous improvement of quality procedures and processes.
- Assist laboratories in preparation for accrediting body notified body FDA or other regulatory inspections.
- Support the preclinical organization in meeting Quality System requirements.
- Support the CAPA process in partnership with CAPA owners.
- Support compliance review meetings in accordance with site procedures.
Qualifications:
Required qualifications:- Bachelors degree in chemistry or related life sciences discipline
- Strong technical and quality knowledge of ISO/IEC 17025 ISO 13485 and/or 21 CFR 58
- Strong verbal and written communication skills both technical and conversational
- Minimum of 3 years experience in a technical role
- Minimum of 2 years experience working in a quality role
- Minimum of 4-5 years experience working in the medical device industry or other similarly regulated industry such as pharmaceuticals biologics or preclinical environments
- Strong experience with 21 CFR 58 (GLP)
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions please visit .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race colour religion sex sexual orientation gender identity national origin disability or status as a protected veteran.
AI Statement: By applying you acknowledge that AI-assisted tools may be used during hiring.
#LI-AS140
Required Experience:
IC
