Spec Quality Assurance

Supports manufacturing process risk identification, evaluation and mitigation for day-to-day operations, new product introduction and continuous improvement of the quality management system.
This position handles multiple projects/programs while keeping to key deadlines.
Integrates knowledge of business and functional priorities to address complex problems and non-standard situations.
Acts as a key contributor in a complex environment and works independently with minimal guidance.

12CRF820
CQE, CSSBB
Experience leading / creating PFMEA and Control plans, applying knowledge of product, process, and observations from operators
ISO 13485
ISO 14971
PPAP close
Supplier / Quality System Auditing
Ability to create and provide training
Ability to create, review and coordinate test protocols and reports
Bachelor of Science in an engineering degree or equivalent
Demonstrates knowledge of process risk management activities and quality management systems
Has knowledge and skills within the Quality Engineering Body of Knowledge.
Minitab or equivalent
MS Word and Excel
Problem solving ability
Strong interpersonal skills