Sr. QA Engineer EMEA, PolandExact Sciences Poland Sp. z o.o. • Poland, Ohio, United States

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Sr. QA Engineer EMEA, Poland

Exact Sciences Poland Sp. z o.o.

Poland, Ohio, United States

Poland, Ohio, United States

Über

Position Overview Sr. Quality Assurance Engineer role provides advanced quality engineering support by leading complex validation, risk management, and change control activities. It ensures regulatory and internal compliance while driving continuous improvement across product development, operations, and supplier management. The position acts as a key technical resource and mentor, promoting quality system harmonization and operational excellence across multiple sites. Essential Duties Lead and execute advanced quality engineering activities including process validation, risk assessments, and supplier quality improvements. Oversee CAPAs, complaints, and audit follow‑up activities ensuring timely and effective resolution. Conduct internal and supplier audits, driving corrective actions and continuous improvement initiatives. Provide quality oversight of EQMS documentation to ensure alignment with global standards (21 CFR 820, ISO 13485, EU IVDR). Mentor junior engineers and technicians on quality system requirements and best practices. Collaborate cross‑functionally to evaluate data trends, identify risks, and implement process enhancements across operations. Qualifications Demonstrated ability to perform the essential duties of the position with or without accommodation. Fluency in English and effective communication in both written and verbal form. Currently authorized to work in the country where the work will be performed on a full or part‑time basis. The company is unable to sponsor or take over sponsorship of employment visas. Affirmative action or disability accommodations can be requested upon contact. Minimum Qualifications Bachelor’s Degree in a science or technical field; or Associate’s Degree and 2 years of relevant experience; or High School Diploma or General Education Degree (GED) and 4 years of relevant experience. 5 years of relevant job‑related experience. Salary Range: 173000,00zł – 284000,00zł (annual base salary)
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Poland, Ohio, United States

Sprachkenntnisse

English

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