Quality Engineer

Description

Job Description The Quality Engineer will provide quality engineering leadership and support for manufacturing process development and production of disposable medical catheters. This role works cross-functionally with Manufacturing, R&D, and Regulatory teams to ensure compliance with all applicable regulatory and quality standards. Key responsibilities include leading process validation activities (IQ, OQ, PQ), supporting test method validation, and ensuring the effectiveness of quality systems across manufacturing operations. The role also supports risk management activities such as pFMEA and control plans, and plays a key role in resolving quality issues related to non-conformances and CAPAs. Additional responsibilities include supporting sterilization validation, environmental monitoring programs, audit readiness, and ensuring proper documentation and compliance with design and manufacturing records (DHF, DMR, DHR). This is a highly visible role within a growing medical device organization focused on delivering innovative, life-saving technologies.

Skills

IQ, OQ, PQ, TMV, pFMEA, GMP, ISO1485, CAPA, NCR, ISO, cleanroom, environmental monitoring, audit, supplier quality, minitab, catheter

Top Skills Details

IQ,OQ,PQ,TMV,pFMEA,GMP,ISO1485,CAPA,NCR

Additional Skills & Qualifications

Bachelor's degree in Engineering, Life Sciences, or related field 2-5+ years of experience in medical device, pharmaceutical, or regulated industry Strong knowledge of FDA regulations and quality standards (ISO 13485, 21 CFR Part 820) Experience reviewing drawings and technical documentation Proficiency in statistical analysis and data interpretation Strong communication, problem-solving, and organizational skills Experience managing competing priorities in a fast-paced environment

Experience Level

Intermediate Level

Job Type & Location

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

Application Deadline

This position is anticipated to close on Jul 9, 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 click.appcast.io 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.