Lead 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 Lead 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 meet the same Quality Standards.

Essential Duties and Responsibilities

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 as required by assigned role.
• 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.
  • 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 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 up to 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’s 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.
• 5+ years of experience in quality principles and practice including experience in assigned area (Design Control, Supplier Management, Risk Management, etc.).
• Design Transfer assignments require 8+ years of experience in process validation principles and practice.
• Manufacturing Support assignments require 8+ years of experience in a manufacturing operation environment.
• 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

• 4+ years of experience in a biotech or 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.

Salary Range:

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 disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

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