BioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens, including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research, aiming to improve patient outcomes by coupling comprehensive clinical data with donor samples. As the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science
Position Summary The Quality Engineer is responsible for supporting and continuously improving BioIVT's Quality Management System (QMS) across multiple sites and business functions. This role provides quality oversight for operations, laboratories, manufacturing, and support processes to ensure compliance with applicable regulatory requirements, industry standards, and customer expectations. The successful candidate will lead risk-based quality initiatives, investigations, CAPA activities, change management reviews, audits, and process improvement projects while serving as a trusted quality partner to cross-functional teams. This position requires a proactive professional with strong analytical, technical writing, and problem-solving skills who can balance compliance requirements with operational effectiveness.
Key Responsibilities
Quality Management Systems
- Support the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
- Ensure compliance with applicable GxP regulations, ISO standards, internal procedures, and customer requirements.
- Participate in Management Review activities and monitor quality system effectiveness.
- Review and approve quality records, procedures, forms, and controlled documents.
Risk Management & Quality Assurance
- Facilitate and document risk assessments for products, processes, suppliers, quality events, and operational changes.
- Apply risk-based decision making to quality system activities and compliance initiatives.
- Provide quality guidance for process improvements, technology implementations, and operational changes.
- Support change control activities and assess potential quality and regulatory impacts.
Investigations, CAPA & Continuous Improvement
- Lead and/or support investigations involving deviations, nonconformances, complaints, quality events, and audit findings.
- Conduct root cause analysis using structured problem-solving methodologies.
- Develop, implement, and verify the effectiveness of Corrective and Preventive Actions (CAPA).
- Identify and drive continuous improvement opportunities that enhance quality, compliance, efficiency, and customer satisfaction.
Audits & Compliance
- Plan, conduct, and support internal audits using a risk-based approach.
- Participate in customer, supplier, certification, and regulatory inspections.
- Document audit findings, communicate risks, and ensure timely closure of corrective actions.
- Support supplier qualification and ongoing supplier quality oversight activities.
Quality Metrics & Data Analysis
- Monitor, analyze, and trend quality system metrics including deviations, CAPAs, complaints, audit observations, training compliance, and change controls.
- Identify emerging quality risks and recommend corrective actions.
- Prepare quality performance reports and dashboards for leadership review.
Training & Documentation
- Develop, review, and maintain SOPs, quality procedures, work instructions, and training materials.
- Deliver and support quality system training across the organization.
- Promote a culture of quality, compliance, accountability, and continuous improvement.
Cross-Functional Collaboration
- Partner with Operations, Manufacturing, Laboratory Services, Supply Chain, Regulatory Affairs, and other functional groups to resolve quality issues and improve processes.
- Act as a quality subject matter expert during project planning, implementation, and execution.
- Provide practical, risk-based quality guidance that supports business objectives while maintaining compliance.
Regulatory & Quality Standards
Maintain working knowledge of applicable requirements, including:
- cGMP, GLP, GDP, and GCP
- FDA regulations and guidance
- ISO 9001 and ISO 13485
- CLIA and CAP requirements
- USP standards
- Human tissue and donor-related regulations
- Data integrity and data privacy requirements
- Applicable federal, state, and international regulations
Qualifications
Education
- Bachelor's degree in Biology, Chemistry, Biotechnology, Engineering, Life Sciences, or a related scientific discipline required.
Experience
- 7-15 years of progressive experience in Quality Assurance, Quality Systems, Manufacturing, Operations, Laboratory, or regulated life sciences environments.
- Demonstrated experience with Quality Management Systems in a regulated environment.
- Experience leading investigations, CAPA, risk assessments, audits, and continuous improvement initiatives.
- Experience supporting regulatory inspections and customer audits preferred.
- Experience with electronic Quality Management Systems (eQMS); MasterControl experience preferred.
Knowledge, Skills & Abilities
- Strong knowledge of quality systems, quality engineering principles, and risk management methodologies.
- Working knowledge of GxP regulations and ISO standards.
- Proficiency in root cause analysis, CAPA management, and process improvement methodologies.
- Ability to analyze quality data, identify trends, and recommend actions.
- Strong technical writing, documentation, and communication skills.
- Excellent organizational, problem-solving, and project management abilities.
- Ability to work independently and influence cross-functional stakeholders.
- Advanced proficiency with Microsoft Office and quality management software.
Travel Requirements
- Remote position with travel as needed to support audits, inspections, training, site visits, and business initiatives.
- Up to 30-40% travel may be required.
Ideal Candidate Profile A successful Quality Engineer will be a well-rounded quality professional with experience across Quality Systems, Risk Management, Auditing, CAPA, Investigations, Change Control, and Continuous Improvement. They are comfortable working independently, influencing stakeholders, managing competing priorities, and helping build a proactive culture of quality across a growing global organization. We offer a comprehensive benefit package for eligible team members, including medical, dental, vision, short-term/long-term disability, life insurance, hospital indemnity and accident insurance. We also provide a generous retirement plan with a company match. Eligible employees enjoy competitive time-off policies and a collaborative environment that promotes growth from within. Enjoy company-sponsored events for the entire team! Join Us! We can’t wait to work with you! At BioIVT, we believe that diversity and inclusion are key drivers of innovation and success. We are committed to creating a workplace where everyone feels valued, respected and empowered to bring their unique perspectives to the table. We seek to build a diverse team and encourage applications from people of all backgrounds, experiences and identities. To Learn more about our mission and team culture, click here! BioIVT is an equal opportunity employer. We celebrate diversity and are dedicated to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. We strongly encourage veterans and individuals with disabilities to apply and are committed to providing reasonable accommodations throughout the application and employment process.