Help us change lives
At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.
Position Overview
The Sr. Quality Assurance Engineer role provides advanced quality engineering support by leading complex validation, risk management, and change control activities. It ensures regulatory and internal compliance while driving continuous improvement across product development, operations, and supplier management. The position acts as a key technical resource and mentor, promoting quality system harmonization and operational excellence across multiple sites.
Essential Duties
Include, but are not limited to, the following:
- Lead and execute advanced quality engineering activities including process validation, risk assessments, and supplier quality improvements.
- Oversee CAPAs, complaints, and audit follow-up activities ensuring timely and effective resolution.
- Conduct internal and supplier audits, driving corrective actions and continuous improvement initiatives.
- Provide quality oversight of EQMS documentation to ensure alignment with global standards (21 CFR 820, ISO 13485, EU IVDR).
- Mentor junior engineers and technicians on quality system requirements and best practices.
- Collaborate cross-functionally to evaluate data trends, identify risks, and implement process enhancements across operations.
- Demonstrated ability to perform the essential duties of the position with or without accommodation.
- Demonstrate fluency in English and communicate effectively in both written and verbal form.
- Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.
Minimum Qualifications
- Bachelor’s Degree in a science or technical field; or Associate’s Degree and 2 years of relevant experience; or High School Diploma or General Education Degree (GED) and 4 years of relevant experience.
- 5 years of relevant job-related experience.
Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.
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Top Skills
What We Do
Exact Sciences is changing the way we think about detecting and treating cancer. As a leader in cancer testing, we are committed to providing earlier answers and life-changing treatment guidance.
