Senior Quality Assurance Engineer

2 months ago


Marshfield, Wisconsin, United States Exact Sciences Full time
Job Title: Senior Quality Assurance Engineer

Exact Sciences is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring the highest quality standards are met in our manufacturing operations.

Key Responsibilities:
  • Represent Quality on various projects and collaborate with business partners to ensure robust materials, products, processes, and systems.
  • 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.
  • Conduct root cause analysis and corrective and preventive actions.
  • Partner with various teams to investigate and resolve issues in a timely manner.
Requirements:
  • Bachelor's degree in a Science or technical field, or Associate's degree in Science or technical field with 2 years of relevant experience.
  • 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 work within a CFR 820, ISO 13485, ISO 9001, and/or cGMP structured environment.
  • Authorization to work in the United States without sponsorship.
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.

Exact Sciences offers a competitive salary range of $98,000.00 to $156,000.00 per year, plus bonus eligibility and company stock. We also offer a comprehensive benefits package, including paid time off, paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits.

At Exact Sciences, we value diversity and inclusion, and we are committed to creating a workplace where all employees can develop personally and professionally with a sense of respect and belonging.



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