Senior Quality Engineer

Basic Purpose of Position: Assist in the development and implementation of Quality Procedures in compliance with ISO13485.

Primary or Major Responsibilities:

Assure  compliance to all Internal Policies and Procedures as well as to all External Standards (QSR, CMDR, ISO 13485 and the EU MDR/IVDR).
Assist in the creation of quality, verification, and validation plans/protocols.
Facilitate process and product corrective actions and problem-solving activities.
Production process review and auditing.
Monitoring and reporting on quality metrics.
Monitor and assess of effectivity of implemented corrective and preventative actions.
Identify opportunities for improvements to the quality system and propose solutions.
Support the development, maintenance, and auditing of the Quality Management system.
Assist in development and implementation of applicable processes to meet Customer requirements, including training, problem solving, and review meetings.
Drive continuous improvement across facility Key Process Indicators.
Participate on cross functional teams to assist with design activities, new product introductions, software upgrades and compliance to new regulations.

Requirements

Bachelor's degree in Engineering field or area of study deemed acceptable by the hiring team.
Minimum of 3 to 5 years engineering experience in related manufacturing position.
Ability to function effectively in a team environment.
Capacity to facilitate problem solving and risk activities on a cross functional team.
Effective communication skills driven by attention to detail.
Experience in risk evaluation techniques, DFMEA, PFMEA & fault tree analysis.
Strong DFM and NPI skills.
Excellent analytical skills using Six Sigma and Lean Principles.
Good working knowledge of quality/reliability engineering statistical techniques.
Self-motivated and self-managed.
Ability to handle multiple projects at the same time.