Quality Assurance Engineer

Job Summary

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The QA Engineer provides support to Regulatory Affairs, Operations and Marketing on design controls, risk management, verification and validation practices, and statistical methods assurance to support product and process development and manufacturing of medical devices in an environment that embraces teamwork, change, risk-based decision making and flexibility.

Essential Functions & Accountabilities:

Support and review process development, including verification/validation, risk management, etc.

Utilize risk-based approach to assess and control manufacturing changes.

Provide quality engineering support of medical device products to ensure that quality requirements are translated into product and process functional specifications.

Support the development of the inspection methodology and acceptance criteria for sampling plans, including the incoming, in-process, final and validation sampling plans.

Support...