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Quality Engineer Medical Device Entry Level Jobs in California

Astrix Inc

Quality Engineer II

Irvine, CA · On-site

$77K - $99K/yr

Pay Rate Low: 40.00 | Pay Rate High: 44.00 Exciting Quality Engineer II development opportunity to ... Working knowledge of ISO 13485, ISO 14971, and medical device quality systems. * Strong ...

UL Solutions

Staff Engineer - Medical Device

Brea, CA · On-site

$115K - $160K/yr

Trains office, field, and/or laboratory staff and entry level engineers. Provides technical ... Performs quality systems and technical audits of customer laboratories. * Performs other duties as ...

Astrix Inc

Instrumentation Quality Engineer

Lake Forest, CA · On-site

$76K - $98K/yr

Medical, Dental, Holiday, PTO 401K matching We are seeking an Instrumentation Quality Engineer to support medical device product development and quality activities. This role partners with R&D, ...

Masimo

Cybersecurity Quality Engineer

Irvine, CA · On-site

$85K - $105K/yr

Exposure to medical device, healthcare technology, embedded systems, or regulated software ... Security+, ISC2 CC, or similar entry-level cybersecurity certification is a plus. Education:

Masimo

Cybersecurity Quality Engineer

Irvine, CA · On-site

$85K - $105K/yr

Exposure to medical device, healthcare technology, embedded systems, or regulated software ... Security+, ISC2 CC, or similar entry-level cybersecurity certification is a plus. Education:

UL Solutions

Staff Engineer - Medical Device

Brea, CA · Hybrid

$115K - $160K/yr

Trains office, field, and/or laboratory staff and entry level engineers. Provides technical ... Performs quality systems and technical audits of customer laboratories. * Performs other duties as ...

UL Solutions

Staff Engineer - Medical Device

Brea, CA · Hybrid

$115K - $160K/yr

Trains office, field, and/or laboratory staff and entry level engineers. Provides technical ... Performs quality systems and technical audits of customer laboratories. * Performs other duties as ...

AllSTEM Connections

Quality Engineer

San Clemente, CA · On-site

$66K - $77K/yr

Position Overview We are partnering with an innovative medical device organization to find a driven Junior Quality Engineer . In this role, you will provide critical quality support for consumable ...

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Quality Engineer Medical Device Entry Level information

What does a quality engineer do in the medical device industry at the entry level?

An entry-level Quality Engineer in the medical device industry is responsible for ensuring that products meet regulatory standards and company quality requirements. They assist with documentation, perform inspections, support process validations, and help investigate product issues or non-conformances. Their role often involves working closely with manufacturing, design, and regulatory teams to maintain compliance with FDA and ISO standards. Entry-level Quality Engineers also help implement quality improvement initiatives and learn about risk management and corrective actions.

What are the key skills and qualifications needed to thrive as an entry level quality engineer in the medical device industry, and why are they important?

To thrive as an Entry Level Quality Engineer in the medical device industry, you need a background in engineering or life sciences, knowledge of quality assurance principles, and familiarity with regulatory standards such as ISO 13485 and FDA 21 CFR Part 820. Proficiency with quality management systems (QMS), root cause analysis tools, and documentation software is typically required, and certifications like CQE can be beneficial. Strong attention to detail, problem-solving abilities, and effective communication are essential soft skills for this role. These competencies ensure products meet safety and compliance standards, supporting patient safety and regulatory approval.

What are some typical challenges entry-level quality engineers face in the medical device industry, and how can they navigate them?

Entry-level Quality Engineers in the medical device industry often encounter challenges such as understanding complex regulatory requirements (like FDA and ISO standards), adapting to strict documentation practices, and communicating effectively with cross-functional teams. To navigate these challenges, it's helpful to proactively seek mentorship, participate in training sessions, and regularly review relevant regulations. Building strong relationships with colleagues in manufacturing, R&D, and regulatory affairs can also foster better collaboration and support personal growth.

What are the most commonly searched types of Quality Engineer Medical Device jobs in California?

The most popular types of Quality Engineer Medical Device jobs in California are:

What are popular job titles related to Quality Engineer Medical Device Entry Level jobs in California?

For Quality Engineer Medical Device Entry Level jobs in California, the most frequently searched job titles are:

What job categories do people searching Quality Engineer Medical Device Entry Level jobs in California look for?

The top searched job categories for Quality Engineer Medical Device Entry Level jobs in California are:

What cities in California are hiring for Quality Engineer Medical Device Entry Level jobs?

Cities in California with the most Quality Engineer Medical Device Entry Level job openings:

Quality Engineer Medical Device Entry Level jobs near you
Infographic showing various Quality Engineer Medical Device Entry Level job openings in California as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 16% Part Time, and 5% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution.

Quality Engineer Medical Device Manufacturing

Dynaflex Technologies Inc.

Irvine, CA • On-site

$76K - $99K/yr

Other

Posted 3 days ago

New

Job description

Company Description DynaFlex Technologies Inc. is a global contract manufacturer specializing in catheter assemblies and thermoplastic extrusion for the medical device industry. The Corporate Headquarters in Irvine and Yorba Linda focuses on catheter technology development and advanced melt extrusion. A Rapid Prototyping Lab in Fremont supports quick-turn delivery systems prototyping and process development. The production facility in Taiwan provides turnkey contract manufacturing services for high-volume commercial builds, enabling end-to-end solutions from concept to scaled production. Team members collaborate across locations to deliver high-quality, innovative products to medical device partners worldwide.

Role Description The Quality Engineer, Medical Device Manufacturing, is a full-time on-site role based in Irvine, CA. This role is responsible for overseeing product quality in catheter manufacturing, including developing and maintaining quality processes, procedures, and documentation in accordance with medical device regulations. Day-to-day tasks include performing inspections and tests, analyzing quality data and metrics, investigating nonconformances, and implementing corrective and preventive actions (CAPA). The Quality Engineer collaborates closely with engineering, production, and supply chain teams to ensure compliant processes, robust validations, and continuous improvement of manufacturing operations. The role also supports internal and external audits, risk management activities, and alignment with customer and regulatory requirements.

Qualifications

  • Demonstrated skills in Quality Engineering and Quality Management for medical device manufacturing.
  • Experience in Quality Control methods, including inspection techniques, testing, and data analysis.
  • Proficiency in Quality Assurance activities, such as documentation control, audits, and compliance with ISO 13485 and FDA regulations.
  • Ability to manage Product Quality, including root cause analysis, CAPA, and continuous improvement initiatives.
  • Bachelor’s degree in Engineering, Science, or a related technical field; advanced degree or relevant certifications (e.g., CQE) are a plus.
  • Familiarity with catheter manufacturing processes, extrusion, and cleanroom production environments preferred.
  • Experience with validation (IQ/OQ/PQ), statistical process control, and risk management tools (e.g., FMEA).
  • Strong communication skills and ability to work collaboratively with cross-functional teams in a regulated environment.

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