Quality Engineer

SMC Ltd. • Devens, MA

73d

About The Position

As a Quality Engineer at SMC Ltd., you’ll play a key role in ensuring that every product we produce meets the highest standards of quality and compliance. You’ll collaborate with cross-functional teams, support continuous improvement initiatives, and contribute to the ongoing success of our rapidly growing organization. Job Summary: Responsible for all areas of Quality Engineering and working directly with the engineering, tooling and manufacturing functions to ensure adequate systems and inspection methods and tools are used throughout the plants for molding or assembling products. Understanding customer requirements and implementing required documentation, action plans, purchasing equipment or tools necessary to perform tasks. Ensure proper controls, operator instructions and quality tools used to verify customer’s products meet specifications at all phases within our process.

Requirements

• 2-4-year college degree or Quality related experience
• Minimum of 1-3 years of experience in a Quality function
• Must be able to read and understand 2D detailed part/article drawings
• Must understand the use all Quality related inspection equipment
• Must have excellent problem solving and mistake proofing skills
• Must have computer skills and familiarity with Word and Excel programs
• Must have knowledge of SPC, ISO 13485, and FDA requirements
• Ability to work well with others and independently
• Excellent written, verbal, and presentation skills

Responsibilities

• Provide Quality Engineering support for the Program Managers on customer programs as required
• Review daily rejects and implement or discuss action plans
• Manage and investigate customer complaints
• Manage CAPAs
• Disposition In-Process rejected product from previous day (MRB), if required
• Make appropriate changes in documentation as required
• Make appropriate changes to fixtures or inspection methods and tools
• Regular attendance and professionalism
• 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
• Create, modify, and maintain History Cards/ Control Plans /Inspection Work Instructions
• Make decisions regarding quality related questions as appropriate
• Contact customers via verbal/written communication as appropriate
• Participate in internal and supplier audits
• Manage print reviews, DCNs and ECOs
• Participate in design reviews as required
• Visit customers and suppliers as warranted
• Participate in plant/department meetings and tours as required
• Work with Engineering, MFG and Tooling to develop corrective actions and continuous improvement activities
• Report any unsafe conditions to Manager or Safety committee member
• Maintain cleanliness of work areas and quality measuring equipment
• Observe all health and safety requirements
• Other duties as assigned

Benefits

• Equal opportunity employer
• Encouragement for applicants from all backgrounds
• Reasonable accommodations during the interview process

What This Job Offers

• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees