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Quality Engineer Medical Device Entry Level Jobs in California

Astrix

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 ...

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

$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 ...

Masimo

Software Quality Engineer II

Irvine, CA · On-site

$75K - $100K/yr

The Software Quality Engineer II is responsible for reviewing software design and development ... Success in this role requires strong knowledge of software quality principles, medical device ...

Masimo

Software Quality Engineer II

Irvine, CA · On-site

$75K - $100K/yr

The Software Quality Engineer II is responsible for reviewing software design and development ... Success in this role requires strong knowledge of software quality principles, medical device ...

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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 69% Full Time, and 31% Contract. Highlights an 100% In-person job distribution.

Quality Engineer II

Irvine, CA • On-site

Astrix
Recruiting and Staffing Services • 1 - 5K employees
Learn more about Astrixexternal

$77K - $99K/yr

Other

Medical, Dental, Vision, Retirement, PTO

Re-posted 8 days ago

Job description

Pay Rate Low: 40.00 | Pay Rate High: 44.00
Exciting Quality Engineer II development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care
Quality Engineer II
Location: Irvine, CA (Onsite)
Contract: 12 month Contract with extension or conversion potential
Benefits: Medical, Dental, Holiday, PTO 401K matching
Pay: 40.00-44.00 doe
Quality Engineer – Medical Devices
Provide hands-on quality engineering support for new product development and design changes for instrumentation products. Partner with R&D, Regulatory, and cross-functional teams throughout the product development lifecycle.
Key Responsibilities
  • Support design controls, risk management, verification/validation, change control, and product transfer.
  • Review and approve design control, risk management, V&V, and development documentation.
  • Provide quality guidance and risk-based decision support to development teams.
  • Assess product and process changes for quality and regulatory impact.
  • Support deviation investigations, root cause analysis, and CAPA activities.
  • Ensure compliance with ISO 13485, ISO 14971, GxP, SOPs, and applicable regulatory requirements.
Minimum Qualifications
  • Bachelor’s degree in Engineering, Life Sciences, or related technical field.
  • 2+ years of Quality Engineering experience in the medical device industry.
  • Experience supporting instrumentation or electromechanical product development in an ISO 13485 environment.
  • Experience with design controls, risk management, change control, and V&V.
  • Working knowledge of ISO 13485, ISO 14971, and medical device quality systems.
  • Strong communication, collaboration, and independent problem-solving skills.
Preferred
  • Experience with statistical methods and V&V study design.
  • Knowledge of IEC 60601 and other applicable product/safety standards.
  • ASQ CQE or Six Sigma certification.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
Work Authorization Requirement
Candidates must be authorized to work in the United States on a permanent basis.
Sponsorship (including H-1B, OPT, CPT, etc.) is not available for this role now or in the future.
INDBH

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