Spec 3, Quality Assurance

• 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

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.

Pay Range: 32-40/hr *based on experience