Job Title:
Senior Quality Assurance Specialist
About the Role:
This position involves providing quality engineering support to various teams. Responsibilities include reviewing validation documentation, change requests, and quality system documentation.
Key Responsibilities:
* Understand and review Validation documentation, Change Requests, and associated Quality System Documentation.
* Provide Quality Engineering support to Research and Development and Sustaining Engineering departments up to and including transfer to Production.
* Liaise with Production and Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process, and Final Quality Control.
* Support the Supplier Appraisal and Approval processes.
* Conducting, documenting, and reviewing complaint investigations.
Requirements:
* Bachelor's degree in Science, Engineering, or a relevant technical discipline.
* Proven knowledge and experience of working with ISO13485, ISO14971, and FDA QSR.
* Familiarity with statistics and Microsoft Office applications.
What We Offer:
* A supportive work environment.
* Opportunities for professional growth and development.