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Lead Quality Assurance Engineer, Supplier Quality

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Exact Sciences

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Location:
United States , Madison

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

112000.00 - 190000.00 USD / Year
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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • 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
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation

Nice to have:

  • 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
What we offer:
  • 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
  • Bonus eligibility

Additional Information:

Job Posted:
January 24, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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