Quality Engineer

Job Description

Job Description

Overview

We are seeking a Quality Engineer to support the development and manufacturing of innovative medical devices in a regulated environment. This position partners closely with Manufacturing, R&D, and Regulatory Affairs teams to drive product quality, support process improvements, and ensure compliance with applicable quality and regulatory requirements.

This is an excellent opportunity for a Quality Engineer looking to expand their experience in validation, quality systems, and cross-functional project support within a growing medical device organization.

Responsibilities

• Support manufacturing and process development activities to ensure product quality and compliance
• Participate in process validation activities, including IQ, OQ, and PQ protocols and reports
• Support test method validation and verification activities
• Investigate non-conformances and assist with CAPA activities
• Collaborate with Manufacturing, Engineering, and Regulatory teams to identify and resolve quality-related issues
• Contribute to risk management activities, including FMEAs and control plans
• Review engineering drawings, specifications, and manufacturing documentation
• Support internal and external audit readiness efforts
• Analyze quality data and identify opportunities for continuous improvement
• Assist with maintaining quality system documentation, including DHF, DMR, and DHR records

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field
• 2+ years of quality engineering experience within a regulated industry
• Experience in medical device, pharmaceutical, biotechnology, or other FDA-regulated environments preferred
• Familiarity with quality systems and applicable regulations, including FDA and ISO standards
• Exposure to process validation, non-conformance investigations, CAPA, or risk management activities
• Ability to interpret engineering drawings and technical documentation
• Strong analytical, problem-solving, and communication skills
• Ability to manage multiple priorities in a fast-paced environment

Preferred Qualifications

• Experience with medical device manufacturing
• Knowledge of ISO 13485 and 21 CFR Part 820
• Experience supporting process validation, test method validation, or risk management activities
• Familiarity with statistical analysis tools and data-driven decision making

Why Join Us?

• Opportunity to work on innovative, life-changing medical technologies
• High visibility across Engineering, Manufacturing, and Quality teams
• Collaborative and growth-oriented environment
• Exposure to a wide range of quality engineering responsibilities and career development opportunities

Job Type & Location

This is a Contract position based out of Carlsbad, CA.

Pay and Benefits

The pay range for this position is $35.00 - $48.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Carlsbad,CA.

Application Deadline

This position is anticipated to close on Jul 16, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.