Job Summary: We currently have an exciting opportunity for a Quality Engineer at our Twinsburg, OH location. Our Quality Engineer will be responsible for all areas of Quality Engineering and working directly with the engineering, tooling and manufacturing functions to ensure adequate systems, inspection methods and tools are used throughout the facility for molding or assembling products. Analyze process capability, standards and recommend improvements to ensure quality, cost, efficiency and customer specifications are met.

Primary Job Duties and Responsibilities:

• Provide Quality Engineering support for the Program Managers on customer programs as required
• Participate in activities concerning the development, implementation and maintenance of quality standards for all programs.
• Responsible for First Article Inspection, PFMEA and Risk Analysis, Capability Studies, and customer driven requirements as required for all programs.
• Coordinates activities in the development of testing methods and test equipment
• Accountable for the accuracy of all product testing
• Maintains all QMS and production process quality documentation and requirements to achieve customer reliability objectives.
• Assist in the training of employees on QMS and process methods.
• Manage internal MRB production processes
• Manage CAPA (Corrective and Preventative Actions)
• Create/Maintain FMEA’s, AQPs, Deviations, Process flows, Validation Plans, IQ/OQ/PQ protocol’s, PPAP’s as appropriate
• Manage, analyze, and create reports for Process Capability studies, FAIR’s, GR&Rs, and other Validation Data before sending to customer
• Internally lead quality audits requested by customer and/or regulatory agencies
• Manage print reviews, DCNs and ECOs
• Perform other duties as assigned

Essential Qualifications

• Bachelor of Science degree from Accredited University/College
• Minimum of 3-6 years of experience in a Quality function
• Understand the use all Quality related inspection equipment
• Excellent problem solving and mistake proofing skills
• Knowledge of SPC and Quality requirements
• Experience in a highly regulated industry
• Ability to collaborate with others and work independently
• Excellent written, verbal, and presentation skills
• All applicants must be authorized to work in the US

Desirable Qualifications

• Experience with ISO 13485 and FDA requirements
• Ability to provide professional, pleasant, supportive interaction with individuals of all levels of technical abilities
• Ability to work with minimal direct supervision
• Ability to read and understand 2D detailed part/article drawings
• Computer skills and familiarity with Word and Excel programs

ADA Requirements

• Typically sits, grasps items and performs keyboarding for frequent operation of a computer
• Stand, walk, bend, reach or otherwise move about occasionally
• Lift, move, or otherwise transfer items up to 30 lbs. occasionally
• Occasional exposure to typical machine shop physical hazards
• Travel by air or car occasionally

At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.

SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.

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