Senior Quality Engineer- Medical Devices

About the role

At Spartronics, every product we build has a purpose — and lives depend on the quality behind it. As a leading Electronic Manufacturing Services (EMS) provider, we partner with top innovators in the medical device, life sciences, aerospace, defense, and industrial markets to deliver electronics that perform flawlessly when it matters most. Our mission is simple but powerful: to be the preferred provider of fail-safe electronic solutions that save lives and protect what matters most.

Responsibilities

• Assure compliance to all internal policies and procedures as well as to all external standards (QMSR, MDSAP, ISO 13485, and EU MDR/IVDR).
• Aid 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.
• Audit internal and supplier audits.
• Monitor and report on quality metrics.
• Monitor and assess the effectiveness 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.
• Aid in the 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 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.