QA Specialist

2 weeks ago


San Jose, California, United States kelly company Full time
Quality Assurance Specialist

Location: San Jose, CA
Employment Type: Full-Time
Shift: 1st Shift
Contract Duration: Until 12/31/2024

Compensation:
$30-34/hr

Kelly Science and Clinical is seeking a Quality Assurance Specialist for a temporary role with a prominent global medical device and biotechnology organization in San Jose, CA. This opportunity offers valuable industry exposure and a chance to advance your career in science and biotechnology. You will be directly involved with innovative medical devices that make a difference in saving lives on a daily basis.

SUMMARY
Auris, a leading technology company, is shaping the future of medical intervention by integrating medical robotics, instrumentation, navigation, and data science. Their platform technology aims to extend the use of robotics across various medical procedures.

The role of the Quality Assurance Specialist involves providing comprehensive support in quality assurance, encompassing inspection, document control, and overall maintenance of the quality management system. This position is crucial for both Research & Development and Operations throughout the product lifecycle. The chosen candidate will utilize SAP for documenting quality transactions and assist in compiling and analyzing quality data.

RESPONSIBILITIES
- Review documents related to Quality Control (QC) testing, receiving inspection, and lot history records to ensure product compliance
- Identify and process Non-Conforming Material Reports when necessary
- Conduct incoming and in-process product inspections
- Develop and implement inspection requirements and sampling plans
- Maintain document files and test records accurately
- Assist in creating and updating inspection procedures and protocols

QUALIFICATIONS
- High School diploma required; Associate's degree preferred
- Minimum of 3 years' experience in Quality Assurance and Quality Control preferred
- Proficiency in FDA medical device Quality Systems Regulations, QSR/ISO 13485, and 21 CFR 820
- Ability to interpret engineering drawings and schematics
- Strong communication and organizational skills
- Technical writing proficiency and familiarity with documentation software
- Problem-solving abilities and familiarity with technical tools
- Previous SAP experience is an advantage
- Knowledge of testing equipment is beneficial

Work Environment:
This role is based in a professional office setting and involves standard office equipment use such as computers and phones.

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