{"schemaVersion":"jobsearcher.job.v1","id":"eae06e96a755931aed458c7d","url":"https://jobsearcher.com/jobs/eae06e96a755931aed458c7d","canonicalUrl":"https://jobsearcher.com/jobs/eae06e96a755931aed458c7d","title":"Quality Engineer","description":"About Us\nSMC 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.\n\nJob Summary\nResponsible 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.\n\nEssential Job Duties and Responsibilities\n\nCreate and maintain pFMEA’s, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports.\n\nAnalyze FAIRs, process and test method validation data before sending to the customer.\n\nLead customer complaints and CAPA investigations as required.\n\nManage ECOs, deviations, and documentation updates as required.\n\nGenerate and maintain applicable quality system documentation as needed.\n\nManage activities for handling healthcare products from receiving to shipping.\n\nAssessing and ensuring compliance through training, auditing, and corrective and preventive actions.\n\nParticipate in customer audits and provide input to any observations.\n\nTrain personnel as required.\n\nReview and discuss daily rejects and implement action plans.\n\nMake appropriate changes to prevent recurrence of quality related issues.\n\nMake appropriate changes to fixtures or inspection methods and tools as required.\n\nMaintain regular attendance and professionalism.\n\nOther Position Duties\n\nMake decisions regarding quality related questions as appropriate.\n\nContact customers via verbal/written communication as appropriate.\n\nParticipate in design reviews as required.\n\nVisit customers and suppliers as required.\n\nParticipate in plant/department meetings and tours as required.\n\nWork with Engineering, Manufacturing and Tooling on continuous improvement activities.\n\nMaintain cleanliness of work areas and quality measuring equipment.\n\nObserve all health and safety requirements and report any unsafe conditions.\n\nOther duties as assigned.\n\nEssential Qualifications\n\nBachelor of Science Degree.\n\n5-10 years of experience as a Quality Engineer in the healthcare industry, with New Product Development or New Product Introduction experience required.\n\nMust have experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation.\n\nMust be able to read and understand 2D detailed part/article drawings.\n\nMust understand the use of all quality related inspection equipment.\n\nMust have excellent problem solving and mistake proofing skills.\n\nMust have computer skills and familiarity with Word and Excel programs.\n\nMust have knowledge of SPC.\n\nEffective interpersonal and problem-solving skills.\n\nNew product development experience - minimum of 2 years' experience.\n\nEstablished track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization.\n\nNice to Have\n\nExperience with validating large-scale automation.\n\nExperience with 21 CFR Part 4 Combination Products.\n\nADA Requirements\n\nBend, squat, climb, grasp, reach, lift or otherwise move frequently for extended periods.\n\nLift, move or otherwise transfer up to 50 lbs. frequently, or more occasionally.\n\nWalk, stand or otherwise move about continuously.\n\nExposure to machine shop physical hazards including chemicals which may require respiratory protection.\n\nTypically sits, grasps items and performs keyboarding for occasional operation of a computer.\n\nBenefits\n\nClean, Climate-Controlled Environment.\n\nStable schedule.\n\nPaid holiday and PTO.\n\nHealth, dental, and vision insurance.\n\n401(k) retirement savings.\n\nLife and disability insurance.\n\nPromotional opportunities.\n\nTraining and career growth programs.\n\nAmazing co-workers.\n\nTuition reimbursement.\n\nEmployee Assistance Program.\n\nWe are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.\n\nAt SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodation during the interview process.\n\nSMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.\n\nApplicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.\n\n#J-18808-Ljbffr","company":"Smc","rawCompany":"smc","city":"Harvard","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-07-21T03:21:11.063Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer","description":"About Us\nSMC 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.\n\nJob Summary\nResponsible 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.\n\nEssential Job Duties and Responsibilities\n\nCreate and maintain pFMEA’s, Control Plans, PPAPs, Master Validation Plans, IQ/OQ/PQ protocols and reports.\n\nAnalyze FAIRs, process and test method validation data before sending to the customer.\n\nLead customer complaints and CAPA investigations as required.\n\nManage ECOs, deviations, and documentation updates as required.\n\nGenerate and maintain applicable quality system documentation as needed.\n\nManage activities for handling healthcare products from receiving to shipping.\n\nAssessing and ensuring compliance through training, auditing, and corrective and preventive actions.\n\nParticipate in customer audits and provide input to any observations.\n\nTrain personnel as required.\n\nReview and discuss daily rejects and implement action plans.\n\nMake appropriate changes to prevent recurrence of quality related issues.\n\nMake appropriate changes to fixtures or inspection methods and tools as required.\n\nMaintain regular attendance and professionalism.\n\nOther Position Duties\n\nMake decisions regarding quality related questions as appropriate.\n\nContact customers via verbal/written communication as appropriate.\n\nParticipate in design reviews as required.\n\nVisit customers and suppliers as required.\n\nParticipate in plant/department meetings and tours as required.\n\nWork with Engineering, Manufacturing and Tooling on continuous improvement activities.\n\nMaintain cleanliness of work areas and quality measuring equipment.\n\nObserve all health and safety requirements and report any unsafe conditions.\n\nOther duties as assigned.\n\nEssential Qualifications\n\nBachelor of Science Degree.\n\n5-10 years of experience as a Quality Engineer in the healthcare industry, with New Product Development or New Product Introduction experience required.\n\nMust have experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation.\n\nMust be able to read and understand 2D detailed part/article drawings.\n\nMust understand the use of all quality related inspection equipment.\n\nMust have excellent problem solving and mistake proofing skills.\n\nMust have computer skills and familiarity with Word and Excel programs.\n\nMust have knowledge of SPC.\n\nEffective interpersonal and problem-solving skills.\n\nNew product development experience - minimum of 2 years' experience.\n\nEstablished track record in demonstrating strong leadership and managerial skills within a team-based, collaborative matrixed organization.\n\nNice to Have\n\nExperience with validating large-scale automation.\n\nExperience with 21 CFR Part 4 Combination Products.\n\nADA Requirements\n\nBend, squat, climb, grasp, reach, lift or otherwise move frequently for extended periods.\n\nLift, move or otherwise transfer up to 50 lbs. frequently, or more occasionally.\n\nWalk, stand or otherwise move about continuously.\n\nExposure to machine shop physical hazards including chemicals which may require respiratory protection.\n\nTypically sits, grasps items and performs keyboarding for occasional operation of a computer.\n\nBenefits\n\nClean, Climate-Controlled Environment.\n\nStable schedule.\n\nPaid holiday and PTO.\n\nHealth, dental, and vision insurance.\n\n401(k) retirement savings.\n\nLife and disability insurance.\n\nPromotional opportunities.\n\nTraining and career growth programs.\n\nAmazing co-workers.\n\nTuition reimbursement.\n\nEmployee Assistance Program.\n\nWe are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.\n\nAt SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodation during the interview process.\n\nSMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.\n\nApplicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.\n\n#J-18808-Ljbffr","datePosted":"2026-07-21T03:21:11.063Z","dateModified":"2026-07-21T03:21:11.063Z","hiringOrganization":{"@type":"Organization","name":"Smc","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Harvard","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"eae06e96a755931aed458c7d"},"url":"https://jobsearcher.com/jobs/eae06e96a755931aed458c7d"}}