Sourced Job
Quality Engineer
Marathahalli, Bangalore
1 year
ISO 13485:201621 CFR 820 (FDA)ISO31000 Risk ManagementDesign DocumentationQuality AssuranceMinitabTechnical WritingProduct DevelopmentResearch and VerificationProcess ImprovementSOP and batch record documentationTotal Quality Management (TQM)Six SigmaManufacturing ProcessesPlastic Injection Mold KnowledgeICH Quality GuidelinesSix Sigma Green BeltProcess DevelopmentRisk AnalysisTeamwork
Job Description:
Job Responsibilities:
- Participate in design control activities for medical device products in compliance with ISO 13485 and FDA QSR (21 CFR 820).
- Lead or support Risk Management activities as per ISO 14971.
- Contribute as a QA team member on development projects, ensuring timely and professional execution of assigned tasks.
- Create, update, and maintain controlled documents (SOPs, Specifications, Methods, etc.) to ensure R&D operations comply with ISO 13485 / 21 CFR 820 / EN requirements.
- Support ongoing continuous improvement of Quality Systems.
- Apply statistical tools to support product development and decision-making.
- Provide Quality System (QS) knowledge and training across the organization as required.
- Participate in routine QA/QS operations and activities.
Knowledge Requirements
- Strong working knowledge of medical device regulations — ISO 13485, FDA QSR, etc.
- Practical experience in Quality or Reliability Engineering, risk analysis, product development, and V&V testing in the medical device industry.
- Demonstrated hands-on experience with Design Control procedures.
- Experience with Phase-Gate product development processes.
- Direct application of statistical methods for quality improvement.
- Understanding of process development, total quality tools, and continuous improvement methodologies.
Skill Requirements
- Strong technical writing skills.
- Familiarity with statistical analysis and tools like Minitab.
- Team player with excellent interpersonal and communication skills.
Desired / Additional Skills (Nice-to-Have)
- Familiarity with Six Sigma methodology.
- Experience in high-volume manufacturing and assembly, especially with plastic injection-molded components.
- Highly disciplined and organized in documentation (plans, requirements, drawings, design reviews, test methods).
- Strong critical thinking, analytical skills, and problem-solving abilities.
- Certifications (Preferred)
- Certified Quality Engineer (CQE)
- Six Sigma Green Belt (SSGB) or Six Sigma Black Belt (SSBB)
