Quality Engineer II

SMC Ltd. • Devens, MA

79d

About The Position

As a Quality Engineer II 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. Responsible for all areas of Quality Engineering on customer programs. Responsible for working directly with the program management, tooling and manufacturing functions to ensure adequate systems, documentation, inspection methods and tools are used throughout the organization for molding and assembling healthcare products. Understanding customer requirements and implementing appropriate controls, documentation, action plans, and tools necessary to perform quality related tasks at all phases within the process.

Requirements

• Bachelor of Science Degree.
• 5-7 years of experience as a Quality Engineer in the healthcare industry.
• Must have experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation.
• Must be able to read and understand 2D detailed part/article drawings.
• Must understand the use of 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.
• Effective interpersonal and problem-solving skills.
• Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization.
• Excellent written, verbal, and presentation skills.

Responsibilities

• Create and maintain pFMEA’s, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports.
• Analyze FAIRs, process and test method validation data before sending to the customer.
• Lead customer complaint and CAPA investigations as required.
• Manage ECOs, deviations, and documentation updates as required.
• Generate and maintain applicable quality system documentation as needed.
• Manage activities for handling healthcare products from receiving to shipping.
• Assess and ensure compliance through training, auditing, and corrective and preventive actions.
• Participate in customer audits and provide input to any observations.
• Train personnel as required.
• Review and discuss daily rejects and implement action plans.
• Make appropriate changes to prevent recurrence of quality related issues.
• Make appropriate changes to fixtures or inspection methods and tools as required.
• Regular attendance and professionalism.
• Make decisions regarding quality related questions as appropriate.
• Contact customers via verbal/written communication as appropriate.
• Participate in design reviews as required.
• Visit customers and suppliers as required.
• Participate in plant/department meetings and tours as required.
• Work with Engineering, Manufacturing and Tooling on continuous improvement activities.
• Maintain cleanliness of work areas and quality measuring equipment.
• Observe all health and safety requirements and report any unsafe conditions.
• 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: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees