Lead Quality Assurance Engineer, Supplier Quality

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Position Overview

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.

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.
• 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 companys 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

• Bachelors degree in a Science or technical field; or Associates degree in Science or technical field and 2 years of relevant experience as outlined in the essential duties in lieu of a Bachelors 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 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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