Lab Quality Engineer II

TALENT Software Services; Arden Hills (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

TALENT Software Services seeks a Lab Quality Engineer II to provide quality support for preclinical laboratories, suppliers and studies worldwide, ensuring compliance with ISO 13485, 21 CFR 820, 21 CFR 58, ISO 10993 and ISO/IEC 17025. The role drives CAPA, inspection readiness and continuous quality improvement across global teams.

Responsibilities include conducting audits, collaborating with quality and lab management on process improvements, and coordinating vendor audits to maintain

Qualifications

• Bachelor's degree in chemistry or related life sciences.
• Strong knowledge of ISO/IEC 17025, ISO 13485 and/or 21 CFR 58.
• Excellent verbal and written communication skills.
• Minimum of 3 years' experience in a technical role.

Responsibilities

• Support quality systems to maintain compliance with applicable regulations and standards.
• Conduct internal and external quality audits of laboratories, procedures and controls.
• Plan, schedule and conduct vendor audits and verify supplier quality.
• Prepare for regulatory inspections and ensure inspection readiness.
• Write and publish audit and quality review reports and drive CAPA closures.
• Support or lead quality projects and maintain appropriate records.

Skills

Quality systems knowledge

Regulatory compliance

Verbal & written communication

Technical experience

Education

Bachelor's degree in chemistry or related life sciences

Job description

Description:

Job Title: Lab Quality Engineer II

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 ISO 13485, 21 CFR 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, elevate 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:

• Bachelor's 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

Preferred qualifications:

• 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)