Quality Assurance Engineer

Responsibilities

• Provide support to operational teams through process validation, facility validation, and test method validation.
• Perform risk assessments and implement mitigation strategies throughout the product lifecycle.
• Create and manage documentation within the Electronic Quality Management System (EQMS).
• Conduct root cause analysis, corrective actions (CAPA), and investigations into nonconformances or deviations.
• Support supplier management by maintaining the Approved Supplier List and assisting with Quality Agreements.
• Represent Quality on various projects, ensuring compliance with ISO, QSR, and other external standards.
• Conduct internal and supplier audits to drive process standardization and continuous improvement.

Requirements

• Bachelor's degree in a Science or technical field (or an Associate degree with 2 years of relevant experience).
• 3+ years of experience in a manufacturing operation environment.
• 1+ years of experience in quality principles and practice (e.g., Design Control, Supplier Management, or Risk Management).
• 1+ years of experience in process validation principles and practice.
• Demonstrated ability to work within CFR 820, ISO 13485, ISO 9001, or cGMP structured environments.
• Ability to travel up to 15% of the time.

Preferred Qualifications

• 3+ years of experience in a biotech manufacturing environment, preferably in a GMP or ISO 13485 environment.
• Certified Auditor (ISO 13485) is a plus.
• Practical experience in FDA and ISO regulated environments.
• Experience with electronic product life cycle (PLM) systems such as Agile.

Benefits

• Paid time off including vacation, holidays, volunteering, and personal time.
• Paid leave for parents and caregivers.
• Retirement savings plan.
• Comprehensive health benefits including medical, prescription drug, dental, and vision coverage.
• Wellness support.

About the Company

Exact Sciences is helping change how the world prevents, detects, and guides treatment for cancer. We provide patients and clinicians with the clarity needed to make confident decisions when they matter most.