Quality Engineer

**About Us:** SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. 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. **Job Summary:** 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. **Essential Job Duties and 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 complaints and CAPA investigations as required. - Manage ECOs, deviations, and documentation updates as required. - Generate and maintain applicable quality system documentation as needed. - Manages activities for handling healthcare products from receiving to shipping. - Assessing and ensuring 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. OTHER POSITION DUTIES: - 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 **Essential 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. - 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 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 - New product development experience- minimum of 2 years' experience - 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 - Typically sits, grasps items and performs keyboarding for occasional operation of a computer **What SMC has to off…