Quality Engineer

About the role

Responsible for all areas of Quality Engineering on customer programs. Works directly with 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. Understands customer requirements and implements appropriate controls, documentation, action plans, and tools necessary to perform quality-related tasks at all phases within the process.

Responsibilities

• Create and maintain PFMEAs, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports.
• Analyze FMEAs, process and test method validation data before sending to the customer.
• Lead customer complaints 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.

Qualifications

• Bachelor of Science Degree
• 5-10 years of experience as a Quality Engineer in the healthcare industry, with New Product Development or New Product Introduction experience required.
• Experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation.
• Experience with reading and understanding 2D detailed part/article drawings.
• Experience with using all quality-related inspection equipment.
• Excellent problem-solving and mistake-proofing skills.
• Computer skills and familiarity with Word and Excel programs.
• Knowledge of SPCE.
• Effective interpersonal and problem-solving skills.
• Minimum of 2 years' experience in new product development.
• Established track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization.

Nice to Have

• Experience with validating large-scale automation.
• Experience with 21 CFR Part 4 Combination Products.
• ADA Requirements: Bend, squat, climb, grasp, reach, lift or otherwise move frequently for extended periods; lift, move or otherwise transfer up to 50 lbs. frequently, or more occasionally; walk, stand or otherwise move about continuously; exposure to machine shop physical hazards including chemicals which may require respiratory protection.

What SMC has to offer

• Clean, climate-controlled environment
• Stable schedule
• Paid holiday and PTO
• Health, dental, and vision insurance
• 401(k) retirement savings
• Life and disability insurance
• Training and career growth programs
• Awesome co-workers
• Tuition reimbursement
• Employee Assistance Program

Company Overview

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.