Quality Engineer Medical Device Expert

Job Overview

Location
Los Angeles
Job Type
Full Time
Date Posted
3 months ago

Job Description

SUMMARY: Management Business Solutions is seeking a Quality Engineer Medical Device Expert for its rapidly growing consumer product client in Los Angeles, CA. The individual in this role will be responsible for overall quality in accordance with both company and customer/retailer requirements, as well as ensuring compliance with international market standards.

RESPONSIBILITIES:

Examine and evaluate new product designs to make sure they comply with the necessary international government, industry, and merchant criteria.
Works closely with the production team and assist in medical device design, development and risk management processes.
Fulfills the quality-related responsibilities of product/process launches.
Collaborates with important outside testing labs and other recognized testing facilities.
Utilizes formal problem-solving tools to research and resolve manufacturing-related issues
Support both existing quality and continuous improvement process, and prevention of non-conforming products.

QUALIFICATIONS:

Bachelor’s Degree in Engineering, Scientific or Business field preferred
3 to 5 years of relevant experience, training in medical device quality assurance, or an equal combination of education and experience.
Knowledge of FDA guidelines and international standards for medical electrical equipment.
Experience with medical device quality is necessary, as well as working knowledge of ISO 13485 and 21 CFR 820 specifications.
Understanding of relevant laws, standards, and regulations. To name a few: CHPA, UL, ASTM, and EN.

MANAGEMENT BUSINESS SOLUTIONS IS AN EQUAL OPPORTUNITY EMPLOYER

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