2

Quality Engineer Medical Device Entry Level Jobs in California

Be Seen First

Medical device industry experience is strongly preferred . * Experience with Quality Engineering and manufacturing processes . * Knowledge of CAPA, MRB, SPC, process validation, audits, and quality ...

New

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 ...

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 ...

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 ...

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 ...

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, ...

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

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

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 ...

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 ...

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 ...

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 ...

next page

Showing results 1-20

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:

Infographic showing various Quality Engineer Medical Device Entry Level job openings in California as of August 2026, with employment types broken down into 74% Full Time, and 26% Contract. Highlights an 100% In-person job distribution.

Quality Engineer Medical Device/SS

Techlink Systems

Alameda, CA • On-site

$50 - $60/hr

Contractor

Medical, Dental, Vision, Retirement

This job post has expired 1 day ago. Applications are no longer accepted.


Job description

Sr. Product Quality Engineer

Location: Alameda, CA – Onsite
Contract Duration: Through March 31, 2027
Work Hours: 8:00 AM – 5:00 PM
Employment Type: Non-Exempt

Job Summary

We are seeking a Sr. Product Quality Engineer to provide engineering and quality support to manufacturing operations. The ideal candidate will have experience in an ISO 9001 environment, preferably within the medical device industry, and strong knowledge of quality systems, process improvement, validation, and statistical techniques.

Key Responsibilities

  • Provide engineering support to In-Process Inspectors and manufacturing operations.
  • Support production activities and process improvement initiatives.
  • Perform trend analysis, process validation, and Statistical Process Control (SPC).
  • Coordinate In-Process Material Review Board (MRB) activities.
  • Support Quality System activities, including internal audits, SOP improvements, and employee training.
  • Participate in CAPA investigations and corrective action activities.
  • Support the successful transfer of new products from R&D to Production from a Quality perspective.
  • Apply and interpret statistical techniques and SPC data.
  • Prepare and present Product Performance Reviews (PPR) and Management Reviews.
  • Collaborate with Engineering, Manufacturing, R&D, and Quality teams to ensure product and process compliance.
  • Ensure manufacturing processes meet applicable quality and regulatory requirements.

Required Qualifications

  • Bachelor’s degree or higher in Mechanical Engineering, Industrial Engineering, or an equivalent engineering discipline.
  • 2+ years of industry experience in an ISO 9001 environment.
  • Medical device industry experience is strongly preferred.
  • Experience with Quality Engineering and manufacturing processes.
  • Knowledge of CAPA, MRB, SPC, process validation, audits, and quality systems.
  • Strong analytical, problem-solving, and communication skills.
  • Ability to work onsite in Alameda, CA, Monday through Friday, 8:00 AM–5:00 PM.

Company Description

TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.

We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.