Nissha Eimo Technologies
Location: Vicksburg, Michigan
Employment Type: Full-Time, Salaried Exempt
Department: Quality Assurance / Engineering
Reports To: Quality Manager Job Summary: We are seeking a highly skilled Quality Engineer with deep expertise in engineering drawing review, GD&T, and quality systems relevant to the automotive, consumer, and medical product industries. This role requires solid knowledge of IATF 16949, ISO 9001, and medical device validation protocols, including IQ, OQ, PQ, and process characterization (PC). The ideal candidate is detail-oriented, hands-on, and capable of collaborating across departments to ensure our products meet the highest standards of quality and regulatory compliance. Key Responsibilities: Interpret and review complex engineering drawings and specifications, applying expert-level understanding of GD&T to assess product and process compliance. Support and perform medical product validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Characterization (PC). Ensure compliance with industry-specific standards including: IATF Automotive Quality Management Systems) ISO 9001 (Quality Management Systems) Medical device quality and regulatory requirements Actively participate in new product launches, ensuring quality requirements are integrated into design, process, and production planning. Develop, document, and maintain standard work instructions for inspection, testing, and manufacturing processes. Conduct first article inspections (FAI) and evaluate results against design specifications. Perform and document risk assessments, process capability studies, and tolerance stack-ups. Drive Corrective and Preventive Actions (CAPA) using structured problem-solving tools (e.g., 8D, 5 Why, Fishbone). Participate in internal and supplier audits, support regulatory and customer audits. Work cross-functionally with Engineering, Manufacturing, and Supply Chain to resolve quality issues and improve processes. Lead or assist with the development of control plans, PFMEAs, and process flow diagrams. Analyze nonconformities, trends, and quality data to support continuous improvement initiatives. Required Qualifications: Bachelor's degree in mechanical, Industrial, Manufacturing Engineering, or related technical field. 2–5+ years of experience in a Quality Engineering role within the automotive, consumer, or medical product industry. Strong proficiency in engineering drawing review and GD&T. In-depth knowledge of IATF 16949, ISO 9001, and medical validation protocols (IQ, OQ, PQ, PC). Experience with precision measurement tools and CMMs. Familiarity with quality tools and methodologies such as FMEA, SPC, 8D, and MSA. Proficient in Microsoft Office and QMS/ERP systems. Strong written and verbal communication skills with a detail-focused mindset. Preferred Qualifications: Experience with Statistical analysis software (e.g., Minitab). Knowledge of PPAP, APQP, and supplier quality processes. Certifications such as CQE (Certified Quality Engineer), Six Sigma Green/Black Belt, or GD&T Professional Certification are a plus. Job Type: Full-time Pay: From $60,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Vision insurance Application Question(s): Do you have IATF 16949 general knowledge of compliance? Have you taken part of IATF 16949 audits? Education: Bachelor's (Required) License/Certification: Certified Quality Engineer (Required) Ability to Commute: Vicksburg, MI Required) Work Location: In person
Employment Type: Full-Time, Salaried Exempt
Department: Quality Assurance / Engineering
Reports To: Quality Manager Job Summary: We are seeking a highly skilled Quality Engineer with deep expertise in engineering drawing review, GD&T, and quality systems relevant to the automotive, consumer, and medical product industries. This role requires solid knowledge of IATF 16949, ISO 9001, and medical device validation protocols, including IQ, OQ, PQ, and process characterization (PC). The ideal candidate is detail-oriented, hands-on, and capable of collaborating across departments to ensure our products meet the highest standards of quality and regulatory compliance. Key Responsibilities: Interpret and review complex engineering drawings and specifications, applying expert-level understanding of GD&T to assess product and process compliance. Support and perform medical product validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Characterization (PC). Ensure compliance with industry-specific standards including: IATF Automotive Quality Management Systems) ISO 9001 (Quality Management Systems) Medical device quality and regulatory requirements Actively participate in new product launches, ensuring quality requirements are integrated into design, process, and production planning. Develop, document, and maintain standard work instructions for inspection, testing, and manufacturing processes. Conduct first article inspections (FAI) and evaluate results against design specifications. Perform and document risk assessments, process capability studies, and tolerance stack-ups. Drive Corrective and Preventive Actions (CAPA) using structured problem-solving tools (e.g., 8D, 5 Why, Fishbone). Participate in internal and supplier audits, support regulatory and customer audits. Work cross-functionally with Engineering, Manufacturing, and Supply Chain to resolve quality issues and improve processes. Lead or assist with the development of control plans, PFMEAs, and process flow diagrams. Analyze nonconformities, trends, and quality data to support continuous improvement initiatives. Required Qualifications: Bachelor's degree in mechanical, Industrial, Manufacturing Engineering, or related technical field. 2–5+ years of experience in a Quality Engineering role within the automotive, consumer, or medical product industry. Strong proficiency in engineering drawing review and GD&T. In-depth knowledge of IATF 16949, ISO 9001, and medical validation protocols (IQ, OQ, PQ, PC). Experience with precision measurement tools and CMMs. Familiarity with quality tools and methodologies such as FMEA, SPC, 8D, and MSA. Proficient in Microsoft Office and QMS/ERP systems. Strong written and verbal communication skills with a detail-focused mindset. Preferred Qualifications: Experience with Statistical analysis software (e.g., Minitab). Knowledge of PPAP, APQP, and supplier quality processes. Certifications such as CQE (Certified Quality Engineer), Six Sigma Green/Black Belt, or GD&T Professional Certification are a plus. Job Type: Full-time Pay: From $60,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Vision insurance Application Question(s): Do you have IATF 16949 general knowledge of compliance? Have you taken part of IATF 16949 audits? Education: Bachelor's (Required) License/Certification: Certified Quality Engineer (Required) Ability to Commute: Vicksburg, MI Required) Work Location: In person