Quality Engineer – ISO 13485

Candidate from Hyderabad and Pune or someone willing to relocate are preferred. Summary We are seeking an experienced Quality Engineer with a strong background in ISO 13485 quality-management systems to support our growing manufacturing operations. The ideal candidate will be proficient in QMS implementation, CAPA management, supplier quality, and process validation within a regulated environment. Experience with injection molding or precision component manufacturing is highly desirable, but the key requirement is the ability to manage and maintain a compliant, efficient, and audit-ready ISO 13485 QMS. Key Responsibilities Quality System & Compliance Maintain and improve the company’s ISO 13485-compliant QMS, ensuring documentation control, change management, and risk analysis meet regulatory expectations. Lead internal audits, management reviews, and support external audits (ISO registrar and customer). Ensure compliance with ISO standards and customer-specific requirements. Develop, revise, and approve quality procedures, forms, and records. CAPA & Non-Conformance Management Lead investigations for non-conformances, customer complaints, and deviations using structured root-cause analysis (5 Whys, fishbone, etc.). Initiate and manage Corrective and Preventive Actions (CAPA) to closure; verify effectiveness and prevent recurrence. Trend quality data and drive continuous improvement using SPC and Lean/Six Sigma tools. Validation & Process Qualification Author and review IQ/OQ/PQ protocols and validation reports for new processes, equipment, or products. Support risk-based process validation planning consistent with ISO 13485 requirements. Collaborate with engineering to ensure proper documentation of design transfer and production readiness. Supplier Quality Support supplier qualification, audits, and performance monitoring. Review supplier CoAs, perform risk-based evaluations, and manage supplier corrective actions. Maintain supplier-quality files and ensure incoming materials meet specifications. Measurement, Inspection & Calibration Support inspection planning, AQL sampling, and FAI documentation. Ensure calibration control and MSA (Gage R&R) for inspection equipment. Review and interpret GD&T on customer drawings; assist inspectors with dimensional analysis. Documentation & Reporting Prepare and maintain validation summary reports, PFMEAs, control plans, PPAPs, and audit records. Generate quality metrics and dashboards for management review. Provide training and support for operators, inspectors, and engineers on QMS procedures. Qualifications Education : Bachelor’s degree in Engineering, Quality, or a related technical discipline. Experience : Minimum 8 years of Quality-Engineering experience in a regulated manufacturing environment. Proven expertise in ISO 13485 implementation, audit readiness, CAPA, and risk management. Experience with injection molding, plastics, or silicone component manufacturing is a plus. Technical Skills: Proficient in QMS software tools, document control systems, and ERP integration (e.g., Odoo, DELMIAWorks, MasterControl). Strong understanding of validation principles, statistical analysis, and data-driven decision-making (SPC, Minitab, DOE). Familiarity with ISO 14971 (risk management) and 21 CFR Part 11 electronic recordkeeping is desirable. Certifications (Preferred): ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA). Six Sigma Green or Black Belt. Soft Skills: Exceptional attention to detail and documentation accuracy. Strong analytical and problem-solving skills. Effective communicator across departments and with customers. Able to thrive in a fast-paced, high-mix manufacturing environment. Performance Metrics: Timely closure of CAPA and non-conformance actions. Successful ISO and customer audit outcomes. On-time completion of validation and QMS documentation deliverables. Reduction in defects, complaints, and audit findings.