Quality Engineer

About the role

The Quality Engineer is responsible for managing and investigating customer complaints associated with oligonucleotide products while ensuring compliant, timely, and effective resolution processes. This role drives product quality improvements through post-market surveillance, root cause investigations, CAPA activities, and cross-functional collaboration to support regulatory compliance and customer satisfaction.

Responsibilities

• Investigate customer complaints by reviewing manufacturing records, analytical data, and product history to determine root cause and product impact.
• Prepare investigation summaries, customer communications, and documentation to support audits, inspections, and regulatory compliance activities.
• Support post-market surveillance activities, including complaint trending, risk identification, and regulatory reporting requirements.
• Partner with Manufacturing, Quality Control, Regulatory Affairs, and R&D teams to identify opportunities for continuous improvement through analysis of complaint data, quality trends, and process performance.
• Initiate and support CAPAs resulting from complaint investigations to improve product quality and process effectiveness.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Engineering, or another related scientific discipline.
• 2+ years of Quality Engineering experience in a regulated or standardized environment such as ISO 9001 or ISO 13485.
• Working knowledge of ISO 13485, 21 CFR 820, 21 CFR 803, Quality System Regulations (QSR), and IVD products.
• Experience conducting structured root cause investigations using methodologies such as 5-Why Analysis, Fishbone Diagrams, DMAIC, or similar problem-solving tools.
• Experience utilizing data analysis tools and quality systems to support investigations, complaint management, and continuous improvement activities.
• Ability to travel up to 5%, including occasional overnight travel.
• Ability to work around chemicals and laboratory-related materials.
• Ability to wear required personal protective equipment, including gloves and safety glasses and perform work in a primarily sedentary environment with occasional lifting of up to 10 pounds.

Preferred qualifications

• Medical device, pharmaceutical, biotechnology, or in vitro diagnostic (IVD) regulated industries experience.
• Advanced degree in a scientific or engineering discipline.
• Six Sigma Green Belt, Black Belt, Certified Quality Engineer (CQE), or similar quality certification.