What are the responsibilities and job description for the Quality Engineer(Medical Devices) position at TekOne IT Services Pvt. Ltd.?
Job Title: Quality Engineer
Duration: 12 Months
Location: CA
Responsibilities
Duration: 12 Months
Location: CA
Responsibilities
- Develop and integrate systems to support compliance and traceability requirements.
- Lead quality planning and continuous improvement initiatives.
- Implement and manage quality systems, software, and records.
- Perform and oversee metrology and calibration activities.
- Ensure adherence to AS9100 or similar quality systems.
- Conduct advanced root-cause analysis and solve complex problems.
- Apply Six Sigma methodologies to enhance processes.
- Collaborate with cross-functional teams to drive quality improvements.
- Provide expert knowledge on product manufacturing, inspection, and technology.
- Maintain a strong understanding of process management, technical specifications, and regulatory guidelines.
- Deliver clear and effective presentations on quality issues and improvements.
- Bachelor’s degree in Engineering or applicable science; Master’s degree is a plus.
- Minimum of 5 years of experience with a Bachelor's degree or 2 years with a Master’s degree.
- Expertise in Quality Planning and Six Sigma.
- Proficiency in quality software, systems, and records management.
- Experience with Metrology and Calibration.
- Familiarity with AS9100 or similar quality standards.
- Advanced root-cause analysis and problem-solving skills.
- Strong knowledge of product manufacture, inspection, and testing technologies.
- Excellent presentation and communication skills.
- Ability to independently develop solutions while adhering to policies.
- Proven ability to work effectively in cross-functional teams.
