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Quality Engineer

3 months ago

Austin, United States Select Source International Full time $30
Job DescriptionJob Description

Responsibilities

·        Set detailed guidelines on what needs to be checked and what the quality standards are

·        Update our Quality Management System (QMS) with incidents, fixes and improvements

·        Audit our systems based on ISO 9001:2015 requirements

·        Determine quality metrics for all manufacturing procedures

·        Monitor the entire production cycle and perform regular tests to identify potential malfunctions as early as possible

·        Inspect product materials and electrical systems for defects and durability

Qualifications:

·        Bachelor’s degree in engineering (Mechanical, Biomedical, or related field).

·        2-5 years of experience in quality engineering within the medical device industry.

·        Knowledge of FDA regulations, ISO 13485, and other relevant standards.

·        Strong problem-solving skills with experience in root cause analysis and CAPA.

·        Proficiency in quality tools and methodologies (e.g., FMEA, Six Sigma).

·        Excellent communication and teamwork skills.

Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.