Senior Quality Assurance Engineer

4 weeks ago

Marshfield, Wisconsin, United States Exact Sciences Full time

About the Role:

The Senior Quality Assurance Engineer will provide support to various operational teams for a variety of functions. This role will work within defined protocols and procedures and may lead or assist in developing and documenting new procedures and processes.

Key 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:

  • 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).
  • 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.

About Exact Sciences:

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.

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.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law.

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