Senior Quality Engineer

As a Senior Quality Engineer at Spartronics, you'll play a pivotal role in the development and implementation of Quality Procedures in compliance with ISO13485.

What a Typical Day Looks Like:

• Assure compliance to all internal policies and procedures as well as to all external standards (QMSR, MDSAP, ISO 13485, and 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.
• Assist in internal and supplier audits.
• 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.
• Oversee Material Review Board activities and approve disposition of discrepant materials.
• 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

The experience we’re looking for to add to the team:

• Bachelor's degree in engineering or area of study deemed acceptable by the hiring team.
• 3-5 years’ engineering experience in a related manufacturing position.
• Experience in risk evaluation techniques, DFMEA, PFMEA & fault tree analysis
• Ability to function effectively in a team environment.
• Capacity to facilitate problem-solving and risk activities on a cross-functional team.
• Strong DFM and NPI skills.
• Self-motivated and self-managed.
• Excellent analytical skills using Six Sigma and Lean principles.
• Ability to manage multiple priorities and drive results in a fast-paced environment.
• Minimal travel may be required.