Lead Quality Assurance Engineer, Supplier Quality

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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.

The Lead Quality Assurance Engineer, Supplier Quality will provide supplier related QA technical and compliance support for commercial, clinical, and future products. This role ensures all suppliers and the materials provided are in compliance with product specifications and regulations, by working directly with suppliers.

This role is a hybrid role working onsite a minimum of 3 days/week at 1 Exact Lane in Madison, WI.

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.
• Product Development 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 13485, 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 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.

• 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.).
• Product Development assignments require 8+ years of experience in product development in the medical device industry with experience in complex systems including software.
• Design Transfer assignments require 8+ years of…