Quality Engineer

ATR International

Santa Ana (CA)

On-site

USD 50,971 - 61,992

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

Job summary

A recruitment firm seeks a Quality Engineer I in Santa Ana, CA. The successful candidate will be responsible for leading complaint investigations in collaboration with various teams and preparing regulatory responses. Ideal for candidates with 0-2 years’ experience, particularly in Class III medical devices, and a strong attention to detail.

Qualifications

0-2 years of experience in a related field.
Experience with Class III medical devices is highly preferred.
Strong analytical skills to evaluate data and trends.

Responsibilities

Lead complaint investigations and analyze product issues.
Collaborate with cross-functional teams for thorough investigations.
Prepare responses for regulatory submissions and inquiries.

Skills

Complaint investigation

Attention to detail

Ability to work under pressure

Job description

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