Quality Engineer

Primary Job Title

While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required.

Quality Engineer

Alternate Job Titles

Validation Engineer

Quality Assurance Engineer

Medical Device Quality Engineer

Process Validation Engineer

Risk Management Engineer

Location

San Diego, CA

Onsite Flexibility

Onsite

Contract Details

Type : Contract

Duration : 6 months

Extension : Possible

Pay Rate : $45 / hr

Shift / Hours : First shift, 8 hours (start between 7 AM – 9 AM)

Job Summary

The Quality Engineer II plays a key role in ensuring compliance and reliability within a medical device environment. This role is responsible for validation activities, including equipment, process, and cleaning validations, as well as risk assessments and quality oversight. The ideal candidate will bring strong validation experience, cross-functional collaboration skills, and problem-solving abilities.

Key Responsibilities

Provide Quality leadership in validation, design transfer, risk management, and specification development.

Author and execute validation protocols and reports (analytical methods, cleaning, processes, equipment, facilities / utilities, raw materials).

Review and approve document change orders, development studies, and change controls.

Generate and maintain process FMEAs and risk assessments for NCEs and deviations.

Support regulatory submissions with validation documentation.

Lead and collaborate with cross-functional teams on new product introduction (NPI) and sustaining projects.

Draft and maintain master validation plans and related departmental procedures.

Participate in Material Review Board (MRB) and Production Response Team (PRT) meetings.

Propose and support process improvements using data-driven approaches.

Provide status updates and escalate issues to management as needed.

Required Experience

Bachelor’s degree in Science or Engineering.

0–2 years in medical device, biotech, diagnostics, or pharmaceutical environments.

Experience in validation methods and process qualifications.

Knowledge of CDRH, CBER, ISO regulations (21 CFR Part 820, ISO 13485, ISO 14971).

Familiarity with 21 CFR Part 11 and electronic document management systems.

Nice-to-Have Experience

Validation experience with custom equipment.

Statistical sampling design and risk assessment experience (PFMEA, SPC).

Project leadership in cross-functional teams.

Required Skills

Strong knowledge of validation and quality processes.

Proficiency in MS Word, Excel, Project.

Solid problem-solving and organizational skills.

Strong cross-functional collaboration and communication.

Preferred Skills

Hands-on experience with risk-based validation approaches.

Knowledge of acceptance sampling and statistical analysis.

Additional Skills

Organized and detail-oriented.

Ability to manage multiple projects concurrently.

Excellent written and verbal communication.

Physical Demands

Ability to sit, stand, walk, kneel, stoop, or crouch as needed.

Lift / move up to 40 lbs.

Work in environments with exposure to chemicals, mechanical equipment, and moderate noise.

Occasional exposure to blood and biological materials.

Benefits

Medical, Vision, and Dental Insurance Plans

401(k) Retirement Fund

About the Client

An innovative medical technology company dedicated to empowering healthier lives with science-based solutions. With a focus on women’s health, the organization provides technologies that detect, diagnose, and treat illnesses earlier — helping millions of people worldwide.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, an Alaska Native-owned company. We proudly serve diverse industries including biotech, healthcare, and technology, connecting professionals with leading career opportunities across the U.S. and Canada.

Job Number & Hashtags

Job Number : 25-26726

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