Quality Engineer
Position Summary
Our client is seeking an experienced Quality Engineer to support and continuously improve the organization's Quality Management System (QMS) across multiple sites and business functions. This individual will serve as a key quality partner, providing oversight for quality systems, investigations, risk management, audits, and compliance initiatives while collaborating closely with cross-functional teams. The successful candidate will help strengthen quality culture, ensure regulatory compliance, and drive continuous improvement efforts throughout the organization.
Key Responsibilities
- Support the development, maintenance, and continuous improvement of the Quality Management System (QMS).
- Lead and support investigations involving deviations, nonconformances, complaints, audit findings, and other quality events.
- Facilitate risk assessments and apply risk-based decision making to quality and compliance activities.
- Manage and support CAPA, change control, and continuous improvement initiatives.
- Conduct and support internal audits, supplier quality activities, and inspection readiness programs.
- Review and approve quality documents, SOPs, work instructions, and controlled records.
- Monitor and analyze quality metrics to identify trends, risks, and opportunities for improvement.
- Partner with Operations, Manufacturing, Laboratory, Supply Chain, and Regulatory teams to resolve quality issues and enhance processes.
- Support regulatory inspections, customer audits, and quality compliance initiatives across the organization.
- Provide quality guidance that balances regulatory requirements with operational effectiveness.
Qualifications
- Bachelor's degree in Engineering, Biology, Chemistry, Life Sciences, or a related scientific discipline.
- 7+ years of experience in Quality Assurance, Quality Systems, Engineering, Manufacturing, Laboratory Operations, or another regulated life sciences environment.
- Strong experience with investigations, CAPA, change control, root cause analysis, and risk management.
- Working knowledge of GxP regulations, FDA requirements, and ISO standards.
- Experience supporting audits, inspections, and quality compliance programs.
- Familiarity with electronic Quality Management Systems (eQMS); MasterControl experience is a plus.
- Strong technical writing, analytical, project management, and problem-solving skills.
- Ability to influence cross-functional stakeholders and work effectively in a fast-paced environment.
Why Join?
This is a highly visible opportunity for an experienced quality professional to make a meaningful impact across a growing organization. The successful candidate will have the chance to drive quality initiatives, influence business processes, support global operations, and help shape a culture focused on compliance, accountability, and continuous improvement. The role offers broad exposure across quality systems, operations, audits, risk management, and regulatory compliance while partnering with teams throughout the business.
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