Quality Engineer (Medical Devices)

TalentBurst, an Inc 5000 company

Irvine (CA)

On-site

USD 48,216 - 57,859

Full time

14 days+

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Benefits offered by this job

Medical Insurance

Vision Insurance

401(k) Plan

Job summary

An established industry player is seeking a Quality Engineer I to ensure the quality and control of manufacturing processes for medical devices. This role involves collaborating with stakeholders, leading investigations into quality issues, and developing risk-based decisions. You'll engage in hands-on troubleshooting and ensure compliance with FDA and ISO standards. Join a dynamic team where your contributions will directly impact product quality and customer satisfaction in a regulated environment. If you are passionate about quality assurance and eager to make a difference, this opportunity is perfect for you.

Qualifications

0-3 years of experience in a regulated industry, FDA environment preferred.
Knowledge of FDA regulations, ISO 13485 standard.

Responsibilities

Develops quality plans to ensure manufacturing continuity.
Leads investigations into production quality issues.
Monitors product performance using statistical methods.

Skills

Root Cause Analysis

Project Management

Data Analysis

Communication Skills

Risk Determination

Education

Bachelor's Degree in Engineering or related field

Tools

Statistical Analysis Software

Quality Management Systems

Job description

2 days ago Be among the first 25 applicants

TalentBurst, an Inc 5000 company provided pay range

This range is provided by TalentBurst, an Inc 5000 company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$35.00/hr - $42.00/hr

Position: Quality Engineer I, Req#: 4979-1

Duration: 12+ Months Contract

Working Hours/Location:

Due to site expansion, specifically looking for candidates who have flexibility in their working hours to move into mid-shift hours, 01:00 PM – 09:00 PM. Prior to this, associates will work normal business hours through a training period before transitioning into a mid-shift schedule.

Job Description:

The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaints and manufacturing investigations, and representing Quality in cross-functional projects.

Education and Experience:

0-3 years of relevant experience in a regulated industry (FDA environment preferred)
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard

Job Responsibilities:

Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
Proficient in project management, data analysis, root cause analysis, communication, and risk determination
Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.

Seniority level