Quality Assurance Engineer

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 Quality Assurance Engineer will provide support to various operational teams for a variety of functions. Based on the scope of the assigned area, activities may include process validation, facility validation, test method validation, risk management, change control, exception management, technology transfer, product development, and supplier management. The position will work within defined protocols and procedures and may lead or assist in developing and documenting new procedures and processes.

This role will also be responsible for driving harmonization of the Exact Sciences QMS so that all sites, including critical suppliers, meet the same Quality Standards.

Essential Duties Include, but are not limited to, the following:

Represent Quality on a variety of projects as assigned.

Communicate and collaborate with business partners to ensure robust materials, products, processes, and systems and compliance to procedures and specifications.

Create documentation and records in the Electronic Quality Management System (EQMS).Perform risk assessments and provide risk mitigation strategies.

Implement processes to monitor product and process performance, compliance, and reliability.

Implement, conduct, and report on process quality programs using statistical data analysis.

Review and approve documentation related to Exact Sciences products.

Conduct periodic reviews of Quality System documentation.

Generate and distribute Quality metrics as assigned.

Generate, prepare, and issue data for assigned quality plans.

Conduct internal and/or supplier audits to drive process standardization and continuous improvement.

Conduct root cause analysis and corrective and preventive actions.

Partner with various teams with timely investigation and resolution of issues to minimize/prevent business disruptions.

Product Development / Product and Process Transfer assignments also include:

Own Risk Management activities throughout the product development process and product lifecycle.

Serve as lead Quality representative providing authoritative guidance on ISO, QSR and external standards requirements to product development core teams.

Accountable for Quality oversight of all Design and Development activities on product development core teams.

Collaborate with product development core team to develop design and development plans, design requirements, design reviews, design V&V documents, risk management documents, and all other design documentation required to support product development.

Supplier Management assignments also include:

Support maintenance of the Approved Supplier List (ASL).Communicate and collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems and compliance to procedures and specifications.

Assist with preparation of Quality Agreements.

Create Supply Base and Supply Base parts in the Electronic Quality Management System (EQMS).Design Transfer & Manufacturing Support Assignments also include:

Lead and assist Operations in the generation, execution, and review of process, test method, and facility qualification/validation and process improvement projects.

Provide Operations support for Investigations, Out-of-Specifications, Nonconformances, Deviations, and material release.

Escalate issues when intervention or a change is necessary.

Excellent oral and written communication skills.

Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.

Support and comply with the company’s Quality Management System policies and procedures.

Regular and reliable attendance.

Ability to collaborate and work effectively in change and exception management.

Ability to frequently and accurately communicate with employees and supporting functions in person, via the…