Quality Assurance Engineer Lead

Company Overview

At Exact Sciences, we strive to change the way cancer is prevented, detected, and treated.

Salary Information

The annual base salary for this position is $98,000.00 - $156,000.00 in the US - WI - Marshfield location on a full-time basis.

About the Job

Job Description

We are seeking a Senior Quality Assurance Engineer to provide support to various operational teams for a variety of functions. Activities may include process validation, facility validation, test method validation, risk management, change control, exception management, technology transfer, product development, and supplier management. The role will work within defined protocols and procedures and may lead or assist in developing and documenting new procedures and processes.

Main 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.
• 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.

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.).
• 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 : $98,000 - $156,000