Principal Quality Engineer in Bedford

Overview Position Summary: The position is responsible to ensure that activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products.
This position provides project/program level leadership, independently develops, applies and implements methods, tools and practices to achieve product quality goals and requirements in the areas of design, development, production, distribution, maintenance and service.
Provides mentoring and consultation to QE staff on relevant issues.
This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, requirements development, risk management, product development and production controls.
The position expected to lead by example in alignment with the company values to achieve objectives.
Responsibilities Key Accountabilities Essential Functions: Participates in the generation and review of quality documents throughout the product lifecycle Advises and directs teams regarding compliance to procedures, standards and regulations Ensures product quality meets requirements and documentation is complete prior to approval Participates on core teams supporting new product development or design changes Defends relevant quality topics in audits and corrective actions to improve and maintain compliance of the QMS Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies.
On projects of significant scope, leads successful implementation of Design Control and Product Realization requirements for design, production and distribution of Werfen products On new product development and or product performance investigations, provides guidance on most appropriate tools and techniques available Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis.
Ensures application of sound statistical methods and quality tools in the evaluation and documentation of results related to design control, purchased part qualifications, V