▷ [Urgent] Quality Engineer – ISO 13485 / Quality Systems

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.