Senior Quality Engineer- Manufacturing

Spartronics Strongsville Inc • Strongsville, OH

just now • Onsite

About The Position

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.

As a Senior Quality Engineer in Strongsville, OH, you’ll play a critical role in advancing that mission by ensuring the quality, compliance, and reliability of the medical device products we produce. You’ll apply your technical expertise and problem-solving skills to maintain the highest standards of excellence — from product design and validation to continuous process improvement. Your leadership and insight help ensure that every product we deliver supports patient safety and improves lives around the world.

Position: Senior Quality Engineer- Electronics Manufacturing
On-Site Work- Manufacturing Plant Location: Strongsville, OH
Citizenship Requirements- US Citizen or US Permanent Resident Only. We can not sponsor Visas due to ITAR compliance regulations.

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

• 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.
• Experience having led a quality audit highly desired.
• 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.
• Due to ITAR regulations, you must be a US Citizen, Permanent Resident, or Green Card Holder. We can not sponsor Visas.

Responsibilities

• 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.

Benefits

• Full range of medical, dental, and vision benefits.
• Flexible Savings Accounts for Medical, Dependent Care, and Limited Purpose (dental and vision only)
• PTO and Holiday Pay
• Company-paid life insurance and disability at 1 times your annual salary at no cost to you, with options to increase coverage amounts
• 401k with a company match of 50% to every dollar up to 6%
• Accident, Critical Illness, Hospital Indemnity, and Legal Insurance optional plans
• Employee Assistance Program
• Tuition Reimbursement
• Opportunities to grow and excel in the Electronics Manufacturing industry at a company that values promotions and learning from within. Every day is different, challenging, and rewarding.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level