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: Bachelors
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.
- Assist 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.
- 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)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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 to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
