Senior NPD Quality Engineer

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Job Function:
Quality

Job Sub Function:
R&D/Scientific Quality

Job Category:
Professional

All Job Posting Locations:
Raynham, Massachusetts, United States of America

Job Description:

The Senior New Product Development (NPD) Quality Engineer provides Quality Engineering leadership on new product development projects in the areas of Design Controls and Design Transfer to Manufacturing including, but not limited to: Risk Management, Design Verification and Validation Strategies, and Design Transfer to Manufacturing.

This role is for our Mitek Sports Medicine organization supporting our soft tissue solution portfolio of products.

DUTIES & RESPONSIBILITIES


* Independently provide directions and oversight of the new product development quality activities across assigned projects.


* Apply various tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions as well as process improvements.


* Apply various risk management and risk mitigation tools and practices, for example, mistake proofing, critical control points, failure mode and effects analysis.


* Supports the reliability assessments of product design.


* Lead root cause investigations using various problem-solving techniques and tools and assess effectiveness of corrective actions.


* Conducts, and supports the development of, test methods in equipment, process, and product qualifications/validations.


* Ensures that process Quality control plans are in accordance with product risk level and are consistently followed.


* Implements and/or maintains, production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).


* Participate in technical reviews as appropriate.

Additional Duties:


* Responsible for communicating business-related issues or opportunities to next management level



* Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.



* For those who supervise or manage a staff, responsible for ensuring that subordinate...