An exciting opportunity exists for a Quality Assurance Specialist to drive process improvements and ensure quality standards in a regulated manufacturing environment.
Job Responsibilities:
* The successful candidate will develop and implement process enhancements to guarantee predictable outcomes across all product lines.
* They will provide effective support to Operations teams, ensuring they meet their objectives of quality, cost, and output.
* The Quality Assurance Specialist will identify and address failure modes in processes by utilizing tools such as Design of Experiments (DOE) studies and Failure Mode Effects Analysis (FMEA).
* They will lead plant-wide quality system improvements while maintaining regulatory compliance with cGMP's for medical device regulatory agencies like the FDA.
* The ideal candidate will manage Incoming Inspection areas efficiently to supply production departments effectively.
* Functional expertise on quality-related issues such as regulatory requirements, statistical techniques, sampling principles will be provided. Additionally, approval of change requests for process changes is required.