Quality Assurance Engineer

Position Overview 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. Essential Duties 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. 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. Support maintenance of the Approved Supplier List (ASL). Assist with preparation of Quality Agreements. Create Supply Base and Supply Base parts in the Electronic Quality Management System (EQMS). 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. 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 telephone, or by email. Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities. Ability to comply with any applicable personal protective equipment requirements. Ability to travel 15% of working time away from work location, may include overnight/weekend travel. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day. Minimum Qualifications Bachelor’s degree in a Science or technical field; or associate degree in science or technical field and 2 years of relevant experience as outlined in the essential duties in lieu of a bachelor’s degree. 3+ years of experience in a manufacturing operation environment. 1+ years of experience in quality principles and practice including experience in assigned area (Design Control, Supplier Management, Risk Management, etc.). 1+ years of experience in process validation principles and practice. Demonstrated ability to successfully work within an CFR 820, ISO 13485, ISO 9001, and/or cGMP structured environment. Authorization to work in the United States without sponsorship. Demonstrated ability to perform the Essential Duties of the position with or without accommodation. Preferred Qualifications 3+ years of experience in a biotech manufacturing environment, preferably in a GMP and/or ISO13485 environment. Certified Auditor is a plus (ISO 13485). Demonstrated experience in support of qualification and monitoring programs. Practical experience in FDA and ISO regulated environments. Experience with electronic product life cycle (PLM) systems such as Agile. Benefits Salary Range: $76,000.00 - $125,000.00. The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible. Exact Sciences offers paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Equal Employment Opportunity We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law. #J-18808-Ljbffr