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 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.