Quality Engineer (Design Development) - Medical Device
Sterling Life Sciences - Los Angeles, CA

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Partial Job Description
1) Develop function and design development activities of Class I and II medical devices in compliance with FDA, ISO, CMDR Quality Systems and Design Control requirements
2) Participate in the design of medical devices and components from design initiation through design transfer by representing Quality Assurance in all design and development project teams
3) Lead multifunctional new product project teams in developing risk assessments, design inputs, test and inspection procedures, acceptance criteria and complaint analysis
4) Determine necessity of testing and initiate testing of assigned products by preparing test and inspection plans
5) Identify and obtain required test fixtures and test / inspection instrumentation
6) Assist with NCMR and MRB activities for assigned products, timely resolution of nonconformities, issue and monitor corrective actions associated with nonconformance and deviations
7) Provide input and direction to other members of the Quality Assurance Department to assist them in assignments and provide learning experience
8) Assist in the maintenance of design history files for assigned projects, adhering to company control procedures and perform periodic review of design history files to ensure timely design transfers
9) Support manufacturing suppliers through selection and approval, audits, corrective and preventive actions, assistance in on-site resolution of quality and process related issues
10) Report progress and status of assigned projects on a timely basis with emphasis on reporting results to Director of Operations

Qualifications / Skills Required
1) University Degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (No students or fresh graduates please)
3) Recent experience in the Medical Device industry is strongly preferred.
4) Preference will be given to people have recent experience in Quality and Design Development