Senior Quality Engineer, Design Quality Job Details:
The position of Senior Quality Engineer, Design Quality is a critical role that oversees the interpretation and application of relevant standards, regulations, and internal procedures in proprietary design and development projects.
Key Responsibilities:
* Ensure that all proprietary design and development projects adhere to applicable regulations, regulatory requirements, international standards, and enterprise and local procedures.
* Identify and support the implementation of improved quality practices by R&D teams during design control activities.
* Review and approve relevant design history file documents, product drawings, component specifications, labeling, and procedures.
* Coordinate and facilitate the completion of projects up to and including performance qualification (PQ).
* Author and/or review and approve Risk Management Plans, risk assessments, and Risk Management Summary Reports for proprietary design and development projects.
* Support updates to enterprise procedures that impact design and development activities.
* Closure of change controls and protocol non-conformance reports (PNRs) is also driven by this position.