Unknown Company

Quality Engineer

santa ana, ca • Posted 1 weeks ago

Onsite Contract Engineering

This range is provided by ATR International. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$37.00/hr - $45.00/hr

Direct message the job poster from ATR International

Recruiting Operations Manager/Technical Recruiter at ATR International

We are seeking a Quality Engineer I for a very important client.

Primary Responsibilities

Leads complaint investigations, conducts periodic trending of complaint data, evaluates negative trends, assesses risk to released products which aids in determining appropriate field actions and analyzes explants and returned products, as required.
Collaborates with cross functional teams like customer quality experience management, clinical affairs, medical safety, R&D engineering and manufacturing to perform thorough complaint investigation.
Prepares appropriate responses to regulatory queries for product registrations and other regulatory submissions by working with the regulatory affairs team.
Partners with design assurance team on risk analysis of new products by reviewing files such as product hazard analysis, DFMECA, post market surveillance plan, risk management report, etc.
Owns and maintains periodic safety update report (PSUR) by collaborating with several cross-functional teams for applicable devices.
Develops solutions to unique issues with wide range of difficulty. Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation across functions and/or businesses which may cause redirection.
Prioritize timely presentation of quality issues and escalate to leadership based on sound engineering, analysis & review for the success of the business.

HM's Top Needs:

Prior complaint investigation on Class III medical device.
Working under pressure and manage stress, able to achieve weekly goals in terms of closing all assigned complaints each week.
Attention to details, avoid repeating errors on routine tasks.

Years’ Experience Required: 0-2 years

Seniority level

Seniority level
Associate

Employment type

Employment type
Contract

Job function

Industries
Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

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