Exact Sciences · 19 hours ago
Lead Quality Assurance Engineer, Supplier Quality
US - WI - Madison
Full-time
Hybrid
Senior Level, Lead/Staff
$112K/yr - $190K/yr
5+ years expExact Sciences is dedicated to changing how the world prevents, detects, and guides treatment for cancer. The Lead Quality Assurance Engineer, Supplier Quality will provide supplier-related QA technical and compliance support for commercial, clinical, and future products, ensuring all suppliers and materials comply with product specifications and regulations.
BiotechnologyHealth DiagnosticsManufacturingMedical
No H1B
Responsibilities
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
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
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)
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
Qualification
Required
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 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
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Preferred
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
Benefits
Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Company
Exact Sciences
Exact Sciences offers a portfolio of cancer screening and diagnostic tests that span from early detection to treatment monitoring.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.75B2025-06-20Acquired
2024-04-11Post Ipo Debt· $620.7M
2023-02-23Post Ipo Debt· $500M
Leadership Team
Kevin Conroy
Chairman & CEO
Aaron Bloomer
Executive Vice President, CFO
Recent News
2026-01-23
legacy.thefly.com
2026-01-23
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