Jobs at SMC Ltd

Lead quality engineering for medical device new product development: create pFMEAs, control plans, PPAP, validation protocols; analyze FAIRs and validation data; lead CAPA and customer complaints; manage ECOs and quality documentation; support audits, training, and cross-functional continuous improvement to ensure compliance with ISO 13485 and 21 CFR Part 820.

Support product quality and compliance for medical-device manufacturing: perform incoming/in-process/final inspections, testing, DHR/DMR documentation, calibration and metrology activities, validations (IQ/OQ/PQ), statistical studies, root-cause investigations, and supplier CAPA/8D management per ISO 13485/9001.

Ensure supplier quality for medical device components by auditing suppliers, managing supplier classification and CAPAs, supporting PPAP/validation, conducting supplier qualifications (MSA, GD&T, FMEA, FAI), contributing to APQP and validation plans, and collaborating with Procurement, Operations, and Quality to resolve issues and drive continuous improvement.

Manage high-volume direct-labor recruiting for a regulated medical device manufacturing site: source, screen, interview, and hire hourly production staff while ensuring FDA/ISO compliance, maintaining ATS/HRIS records, running hiring events, partnering with operations and staffing agencies, and tracking recruiting metrics to improve retention and time-to-fill.

Design, develop and improve manufacturing processes and equipment to meet product and quality requirements. Lead projects from concept to production launch, create work instructions and validation protocols, reduce waste, support quoting/production, and implement process improvements and automation to improve efficiency, cost, safety, and quality.

Manage full-cycle recruitment at a manufacturing site: source and hire candidates, build talent pipelines and partnerships, coordinate campus and vendor programs, advise hiring managers, improve recruiting metrics and candidate experience, and support onboarding and HR initiatives.

Strategic, hands-on HR partner for multi-site operations. Lead employee relations, compliance, talent management, performance and compensation programs; supervise and develop HR staff; manage workers' compensation and OSHA compliance; analyze HR metrics and drive engagement and retention initiatives.

Drive market planning, business development, and customer relationship activities. Prepare presentations, quotations, and sales documentation; support trade shows, invoicing, dispatch, and QMS updates. Collaborate with internal teams, visit customers and plants for technical support, and maintain quote/order logs.

Lead development of new medical device manufacturing projects from quotation through mold/tooling design, process development, validation, and transfer to production. Manage timelines, customer deliverables, testing/DOE, validation reports, and Device Master Record (DMR) creation. Provide technical support post-release and ensure compliance with engineering standards, safety, and quality requirements.

Perform assembly and production tasks on assigned weekday shifts in a medical manufacturing facility. Follow oral and written instructions, perform counting and basic math, communicate in English, work effectively in teams, and operate with minimal supervision. High school diploma and at least one year production experience required; assembly/medical manufacturing experience preferred.

Support HR functions including onboarding, benefits and leave administration, recruiting non-exempt/temporary staff, maintaining HRIS (ADP), employee relations, training, policy administration, and special projects in a manufacturing environment.

Lead quality engineering for medical device programs: develop pFMEAs, control plans, validations (IQ/OQ/PQ), analyze FAIRs, manage CAPA/ECOs, support audits, train staff, and implement corrective actions to ensure compliance with ISO 13485 and 21 CFR 820.

Administer the LMS (course creation, enrollment, tracking, reporting) and support QMS compliance by planning and leading internal audits, coordinating auditor training, and managing CAPA and complaint processes to ensure timely investigation, resolution, and continuous improvement.

Design and document electrical control panels and schematics for automated medical device manufacturing systems. Coordinate PLC/HMI I/O, select components, produce wiring harnesses and BOMs, support panel builds and commissioning, and ensure documentation meets FDA traceability and relevant safety standards.

Lead and implement Lean and continuous improvement initiatives across manufacturing (molding) to improve efficiency, quality, and productivity. Drive Kaizen events, value stream mapping, standard work, root cause analysis, KPI monitoring (OEE, yield, cycle time), NPI support, training, and cross-functional project leadership using Lean, Six Sigma, and data analysis.