Quality Engineer(Medical Devices)

TekOne IT Services Pvt. Ltd. • Full-time • Pleasanton, CA, United States • 4m ago

Job Title: Quality Engineer

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.

Education Requirements

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.

Desired Skills

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.

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