*Applicants must be authorized to work in the U.S. without visa sponsorship.
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 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.
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)
