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Spartronics · 1 day ago

Senior Quality Engineer- Manufacturing

Strongsville, OH

Full-time

Onsite

Mid, Senior Level

3+ years exp

Spartronics is a leading Electronic Manufacturing Services provider focused on delivering fail-safe electronic solutions. As a Senior Quality Engineer, you will ensure the quality, compliance, and reliability of medical device products, applying technical expertise to maintain high standards of excellence and drive continuous improvement efforts.

ManufacturingSemiconductor

No H1B

U.S. Citizen Only

Hiring Manager

Jenny B.

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

Qualification

ISO 13485DFMEAPFMEASix SigmaLean principlesQuality Management SystemAnalytical skillsProblem-solvingTeam collaborationSelf-motivated

Required

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

Due to ITAR regulations, you must be a US Citizen, Permanent Resident, or Green Card Holder. We can not sponsor Visas

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.