$80K — $100K *
* Core Team Member supporting new product development and sustaining engineering projects across multiple sites.
* Act as a coach and mentor in the Product Quality Engineering team and cross-functionally to build and develop skills and competencies of others .
* Subject matter expert for customer and patient focused, end to end Risk Management.
* Supports complaint investigations, signal detection, product issue escalations.
* Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP).
* Other Quality Assurance responsibilities as assigned by Management.
* Bachelor's degree or equivalent in an engineering or life science discipline
* Minimum of 8 years of professional experience or equivalent training/education in Quality or other Engineering disciplines.
* Minimum of 5 years working in medical device new product development.
* MBA or other advanced degree strongly preferred.
* Proven track record in New Product Development delivering on robust, customer and patient focused product quality, Concept through Post-Launch.
* Strong technical skills related to product quality including VOC translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics.
* Strong working knowledge of FDA QSR’s, MDSAP, ISO 13485, Design Controls, Human Factors and Risk Management practices.
* Strong working knowledge of technical problem solving skills. Design or Process Green / Black Belt is a plus.
* Strong collaboration skills and the ability to work across functions.
* Must be a change agent, highly and effectively organized, be a flexible self‑starter, team-oriented and excellent at prioritization and multitasking.
Valid through: 6/30/2021
$80K — $100K *
7 days ago