SMC Ltd
Overview
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Quality Engineer II
role at
SMC Ltd . Get AI-powered advice on this job and more exclusive features. About The Opportunity
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. 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 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. 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. 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 5-7 years of experience as a Quality Engineer in the healthcare industry Experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation Ability to read and understand 2D detailed part/article drawings Proficiency with quality related inspection equipment Excellent problem solving and mistake proofing skills Computer skills with Word and Excel Knowledge of SPC Effective interpersonal and problem-solving skills Established track record in demonstrating strong leadership and teamwork in a matrix organization Excellent written, verbal, and presentation skills ADA Requirements
Typically sits, grasps items and performs keyboarding for frequent operation of a computer Stand, walk, bend, reach or otherwise move about regularly Lift, move, or otherwise transfer items up to 40 lbs.; >20 lbs. frequently Occasional exposure to typical machine shop physical hazards Travel by air or car frequently Company Information
At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. We are 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Medical Device
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Join to apply for the
Quality Engineer II
role at
SMC Ltd . Get AI-powered advice on this job and more exclusive features. About The Opportunity
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. 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 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. 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. 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 5-7 years of experience as a Quality Engineer in the healthcare industry Experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation Ability to read and understand 2D detailed part/article drawings Proficiency with quality related inspection equipment Excellent problem solving and mistake proofing skills Computer skills with Word and Excel Knowledge of SPC Effective interpersonal and problem-solving skills Established track record in demonstrating strong leadership and teamwork in a matrix organization Excellent written, verbal, and presentation skills ADA Requirements
Typically sits, grasps items and performs keyboarding for frequent operation of a computer Stand, walk, bend, reach or otherwise move about regularly Lift, move, or otherwise transfer items up to 40 lbs.; >20 lbs. frequently Occasional exposure to typical machine shop physical hazards Travel by air or car frequently Company Information
At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. We are 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Medical Device
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