Quality Systems Specialist

SpartronicsDescription: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 Quality Systems Specialist in Strongsville, OH, you'll play a critical role in advancing that mission by leading and supporting the development and implementation of quality procedures in compliance with ISO-13485 and FDA QSR.Position: Quality Systems SpecialistOn-Site Work- Manufacturing Plant Location: Strongsville, OHCitizenship Requirements- US Citizen or US Permanent Resident Only. We cannot sponsor Visas due to ITAR compliance regulations.As a Quality Systems Specialist in Strongsville, OH, you'll lead and support the development and implementation of quality procedures in compliance with ISO-13485 and FDA QSR.What a Typical Day Looks Like:- Manage customer complaints and maintain all related documentation.u00a0- Lead and/or support internal and supplier audits.u00a0- Contribute to the development, maintenance, and auditing of the Quality Management System (QMS).u00a0- Support the CAPA process by assisting in the development and implementation of procedures to meet customer requirements, including training, problem-solving, and review meetings.u00a0- Drive continuous improvement initiatives aligned with key facility performance indicators.u00a0- Act as regulatory resource to ensure compliance with new and existing requirements.u00a0- Drive continuous improvement initiatives aligned with key facility performance indicators.u00a0- Lead project and investigation teams, providing direction and oversight.u00a0- Develop and present reports to monitor facility performance and key metrics.u00a0- Serve as the primary point of contact for customers regarding documentation issues and approvals (e.g., ECNs, deviations, drawings, BOMs).- Identify opportunities for database improvements and oversee development, verification, and validation of systems supporting manufacturing and documentation.u00a0- Collaborate cross-functionally to ensure documentation and processes accurately support manufacturing operations.u00a0- Develop and deliver quality-related training programs.u00a0Requirements:The experience we're looking for to add to the team:- Bachelor's degree in engineering discipline or related field seemed acceptable by the hiring team.- 3-5 years of quality experience in a related environment. u00a0- Proven ability to work effectively in a team setting.u00a0- Strong attention to detail with excellent written and verbal communication skills.u00a0- Solid analytical capabilities, including experience with Six Sigma and Lean methodologies.u00a0- Working knowledge of quality statistical techniques.u00a0Due to ITAR regulations, you must be a US Citizen, Permanent Resident, or Green Card Holder. We can not sponsor Visas.Our Commitment:At Spartronics, we're dedicated to fostering an inclusive, diverse, and equitable workplace. We believe that diverse perspectives drive innovation, and we welcome candidates of all backgrounds to apply. Our culture at Spartronics values accountability, unity, respect, transparency and excellence. These winning values are the lifeblood of our business. We embrace diversity through people who believe in these valu

Created: 2026-04-20