Manufacturing Quality Engineer
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- 모집기간 : 채용시까지
◈ 직무 개요
- Identify problems related to (DFM) Design for Manufacturability and implement corrections.
- Verify documentation of critical manufacturing steps, inspection results, process parameters, equipment calibration, and operator training records.
- Ensure DHRs include all necessary documents, including Batch or lot records, Component traceability, Labeling verification, Test and inspection results, Nonconformance reports (if any) and their resolutions.
- Maintain traceability between DHR, DHF (Design History File), and DMR (Device Master Record) as required.
- Proficient in conducting root cause analysis (RCA) for production issues using structured methodologies such as 5 Whys, Fishbone (Ishikawa) diagrams, Fault Tree Analysis (FTA), and Failure Mode and Effects Analysis (FMEA) to identify and resolve recurring quality problems.
- Collaborate with production and engineering teams to ensure process control, capability, and reliability.
- Develop and monitor Control Plans, PFMEA, and Process Flow Diagrams
- Support first article inspections (FAI), incoming, in-process, and final inspections.
- Develop Test Methods and improve existing test methods to reduce variability caused by the gages and external influences.
- Develop Test Method Validation Protocols and execute them effectively.
- Analyze manufacturing data to identify trends and improvement opportunities using tools like Pareto, SPC, DMAIC.
- Lead continuous improvement projects (Lean, Six Sigma) to reduce scrap, improve yield, and eliminate waste
- Participate in cross-functional improvement teams and contribute to process optimization.
- Support nonconformance investigations and assist with documenting using established procedures.
- Participate in risk management activities.
- Collaborate with cross-functional teams (R&D, Clinical, Regulatory Affairs) to ensure product and process quality.
- Ensure proper document and record management resourcing are established to support the growth of the company.
- Verify documentation of critical manufacturing steps, inspection results, process parameters, equipment calibration, and operator training records.
- Ensure DHRs include all necessary documents, including Batch or lot records, Component traceability, Labeling verification, Test and inspection results, Nonconformance reports (if any) and their resolutions.
- Maintain traceability between DHR, DHF (Design History File), and DMR (Device Master Record) as required.
- Proficient in conducting root cause analysis (RCA) for production issues using structured methodologies such as 5 Whys, Fishbone (Ishikawa) diagrams, Fault Tree Analysis (FTA), and Failure Mode and Effects Analysis (FMEA) to identify and resolve recurring quality problems.
- Collaborate with production and engineering teams to ensure process control, capability, and reliability.
- Develop and monitor Control Plans, PFMEA, and Process Flow Diagrams
- Support first article inspections (FAI), incoming, in-process, and final inspections.
- Develop Test Methods and improve existing test methods to reduce variability caused by the gages and external influences.
- Develop Test Method Validation Protocols and execute them effectively.
- Analyze manufacturing data to identify trends and improvement opportunities using tools like Pareto, SPC, DMAIC.
- Lead continuous improvement projects (Lean, Six Sigma) to reduce scrap, improve yield, and eliminate waste
- Participate in cross-functional improvement teams and contribute to process optimization.
- Support nonconformance investigations and assist with documenting using established procedures.
- Participate in risk management activities.
- Collaborate with cross-functional teams (R&D, Clinical, Regulatory Affairs) to ensure product and process quality.
- Ensure proper document and record management resourcing are established to support the growth of the company.
◈ 경력 요건
- Bachelor’s degree in mechanical engineering, Industrial Engineering, Biomedical Engineering, or related field
- 3–4 years of quality engineering experience in regulated manufacturing environments.
- Working knowledge of ISO 13485, 21 CFR 820, AS9100, or GMP regulations.
- Proficiency with quality tools: CAPA, FMEA, MSA, SPC, RCA, Lean/Six Sigma.
- Strong understanding of GD&T, engineering drawings, and metrology tools
- Proficiency in Microsoft Office 365 Tools.
- Ability to work collaboratively in a fast-paced, dynamic environment.
- 3–4 years of quality engineering experience in regulated manufacturing environments.
- Working knowledge of ISO 13485, 21 CFR 820, AS9100, or GMP regulations.
- Proficiency with quality tools: CAPA, FMEA, MSA, SPC, RCA, Lean/Six Sigma.
- Strong understanding of GD&T, engineering drawings, and metrology tools
- Proficiency in Microsoft Office 365 Tools.
- Ability to work collaboratively in a fast-paced, dynamic environment.
◈ 우대 사항
- Startup experience.
- Experience with medical devices, implantable products, or Class II/III devices.
- Excellent communication skills.
- Familiarity with product traceability
- Strong problem-solving skills and attention to detail.
- Experience with automated inspection or vision systems
- Experience with medical devices, implantable products, or Class II/III devices.
- Excellent communication skills.
- Familiarity with product traceability
- Strong problem-solving skills and attention to detail.
- Experience with automated inspection or vision systems
◈ 제출 서류 및 기타
- 국/영문 이력서 및 자기소개서
◈ 담당 컨설턴트
- 이건교 / 02-2016-6602 / [email protected]
`25.07.24(updated. `25.07.25)