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Position – Quality Engineer/ Sr. Quality Engineer
Location – Gurgaon, Haryana
Who we want:
- Dedicated achievers : People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
- Hard-working winners: Confident, competitive and results-oriented salespeople who create a track record of success.
- Collaborative partners : People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- Analytical problem solvers: People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
What you will do:
- Actively contribute towards complaints handling and complaints investigations. Interfaces with divisional counterparts in US and elsewhere to work on Ops deliverables. Work with divisional counterparts to establish the communication plan with different departments, follow-up with stakeholders to complete the project within timelines, resolve any pending issues.
Roles and Responsibilities
- Customer complaint handling
- Should be able to document, review, evaluate and investigate responses to product complaints
- Performs collective analyses of product complaints and reports for trends and identification of potential corrective or preventive actions
- Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints.
- Collaborates with team members to do complaint investigations
What you need:
- Good analytical and problem-solving skills.
- Knowledge of DFMEA/PFMEA/Control plan/7QC tools.
- 2-3 years of relevant work experience.
- Proficient computer skills in Excel and Word.
- 4D problem-solving methodology.
- Experience is 7 QC tools – Fish Bone Diagram, Pareto Charts, and Root Cause Analysis.
- Good understanding of database management of complaint records.
- Prior experience using complaints processing software
- Excellent documentation and communication skills.
- Excellent analytical skills.
- Effective interpersonal communications skills.
- Blueprint/Engineering schematic reading and interpretation.
- Basic PC skills.
- US FDA quality regulations 21CFR part 820
- ISO 13485 standards
- NC/CAPA process
- Trackwise and windchill knowledge
- Education – Bachelors in Mechanical/Biomedical/Biotech Engineering.
- Experience: 1-3 + years
- Work From Home: Not available
- Travel Percentage: Up to 25%
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