This position is responsible for overseeing manufacturing and product quality activities, working closely with the Manufacturing and Process Engineering teams to support ongoing production, drive continuous improvement, and expand manufacturing capacity.
Contract role: 5 months with possible extension
Required:
- 2 to 4 years of applied experience in the quality assurance field in a regulated environment
- Applied experience in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, MDD, IVDD, and CMDR) desired.
- Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP), manufacturing execution systems (MES).
- Quality System tools (e.g., electronic CAPA/NC, Change Management systems).
- Bachelor's degree in an engineering or scientific discipline.
location: SAN DIEGO, California
job type: Contract
salary: $35.50 - 44.25 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Offer continuous quality engineering support across the entire product life cycle.
- Support manufacturing functions with validation planning and transfer activities.
- Ensure non-conformances, CAPA records, investigations, and corrective actions are adequate.
- Gain familiarity with relevant technology for effective participation in technical discussions and risk-based decision-making.
- Review equipment onboarding, calibration, and maintenance tickets; identify potential GMP compliance gaps.
- Review change requests, notices, and approvals for compliance with requirements in relevant WIs/Procedures.
- Develop and execute strategies to close gaps efficiently and in compliance.
- Coordinate issue resolution using a risk-based approach.
- Ensure manufacturing processes comply with FDA and ISO standards.
- Analyze and report quality data to improve product and processes; provide data-driven recommendations.
- Update management on responsibilities, progress, and timely escalation of issues.
qualifications:
- Experience level: Experienced
- Minimum 3 years of experience
- Education: Bachelors
skills:
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 health, an incentive and recognition program, and 401K contribution (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 in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
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.
