What are the responsibilities and job description for the Quality Assurance Engineer position at Exact Sciences?
Help us change lives
At Exact Sciences, we're helpingchange 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.
- 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.
Minimum Qualifications
Preferred Qualifications
LI-HE1
Salary Range :
61,000.00 - $98,000.00
The annual base salary shown is for this position located in US - WI - Marshfield on a full-time basis. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually.
Exact Sciences is proud to offer an employee experience that includes 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. Learn more about our benefits.
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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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company's affirmative action program.
To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.
Salary : $61,000 - $98,000
