Lab Quality Engineer

Position: Lab Quality Engineer III

Location: Arden Hills, Minnesota - (on-site)

Contract: 12+ months

Job Description:

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 workinstructions, 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 applicableregulations and standards.requests and ongoing vendor needs.through facility- and process-based audits and quality monitoring activities.technical staff.distribute findings to responsible stakeholders.and support timely closure.appropriate records.and processes.regulatory inspections.requirements.Qualifications:Required qualifications:

• Plan, schedule and conduct vendor audits.
• Partner with global preclinical teams and Strategic Sourcing regarding new vendor
• Evaluate the adequacy and compliance of systems, operations and practices
• Assess the accuracy, validity and overall quality of preclinical study data.
• Communicate final results of quality reviews and audits to management and
• Write and publish audit and quality review reports, obtain appropriate approvals and
• Oversee follow-up of corrections and corrective actions, escalate overdue items
• Support or lead assigned quality projects and initiatives.
• Track audits and responses, support document review activities and maintain
• Contribute to the development and continuous improvement of quality procedures
• Assist laboratories in preparation for accrediting body, notified body, FDA or other
• Support the preclinical organization in meeting Quality System
• Support the CAPA process in partnership with CAPA owners.
• Support compliance review meetings in accordance with site procedures.
• 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 preclinicalenvironments
• Strong experience with 21 CFR 58 (GLP)

Pay: $56.00 - $59.00 per hour

Expected hours: 40.0 per week

Work Location: In person