Quality Engineer II

Job Summary

Seeking a skilled Quality Engineer II for an exciting 5-month contract on-site in San Diego, CA. Joining a collaborative 8-10 person team with a Top-Tier Global Pharma Leader, you will drive validation strategies and quality reviews in a fast-paced environment. This role offers flexible first-shift hours and excellent potential for extension.

location

San Diego, California

job type

Contract

salary

$40.00 - 45.98 per hour

work hours

9 to 5

education

Bachelor's degree in Science or Engineering

Responsibilities

• Author and execute comprehensive validation protocols, strategies, and reports for equipment (freezers, fridges, chambers), facilities, and processes.
• Lead cross-functional teams to author process risk assessments, including pFMEAs, Non-Conformance Events (NCEs), and planned deviations.
• Review and approve development studies, change control requests, and document change orders to ensure robust GMP compliance.
• Provide Quality Engineering leadership during New Product Introduction (NPI) and sustaining projects, establishing clear validation strategies.
• Aid in developing departmental procedures, tracking quality metrics, and updating controlled documentation.

Qualifications

• Required: Bachelor's degree in Science or Engineering.
• Minimum 3 years of Quality Engineering experience in a biotech, medical device, or pharmaceutical environment.
• Proven hands-on experience authoring validation protocols and executing risk assessments (pFMEA).
• Strong working knowledge of change control processes and GMP documentation requirements.
• Proficiency with MS Office (Word, Excel, Project) and Electronic Document Management Systems.
• Ability to lift/move products weighing up to 40 pounds and wear required lab PPE.

Preferred Experience

• Experience with validation protocols for custom equipment and statistical sampling.
• Working knowledge of FDA (21 CFR Part 820/Part 11) and ISO 13485 regulations.

skills

• Quality Assurance (QA)
• Quality Control (QC)
• Quality Control Testing
• Quality Management Systems (QMS)

Benefits

• Medical
• Prescription
• Dental
• Vision
• AD&D
• Life Insurance
• Short-term Disability
• 401K Plan

Equal Opportunity Employer

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay Offered

The pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Additional Information

• Comprehensive benefits package available.
• Medical, prescription, dental, vision, AD&D, and life insurance offerings.
• Short-term disability coverage.
• A 401K plan (all benefits are based on eligibility).

Legal Compliance

• San Francisco Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• California Fair Chance Act