Purpose: The Plant Quality Assurance (QA) Senior Associate will report to a Senior QA Manager and is a core member of the site QA team. This individual will act as a Quality point of contact for manufacturing operations, overseeing medical device assembly, serialized packaging, and labeling.
Responsibilities:
* Perform all activities in compliance with safety standards and standard operating procedures.
* Oversight and real-time quality support for manufacturing on the floor.
* Manual pack check and deft assessment
* Batch Review to support customer complaint investigations
* Quality support for triage and investigation of deviation events
* Review/approve deviations for closure ensuring compliance with standards
* Review/approve production batch records and associated documentation
* Provides training and advice to staff for desired functions
* Write, review and approve standard operating procedures
* Support continuous improvement initiatives
* Perform other tasks/projects assigned by managers
Requirements:
* Strong attention to detail for task execution and QA review
* Ability to assess risk and make decisions based on impact and suggested path-forward
* Excellent written and verbal communication skills
* Strong organizational skills for following assignments through to completion
* Knowledge of applicable Regulatory requirements
* Operational Excellence / Continuous improvement experience
Qualifications:
* Science Degree or Engineering degree