A Quality Engineer is needed for a manufacturing company considered one of the world's leading innovators in materials science in the Woodland, CA area. This role involves developing and maintaining the Quality Management System (QMS) and regulatory compliance for serum products, ensuring adherence to standards like ISO 13485 and 21 CFR 820, and managing related projects and customer inquiries.
location: Woodland, California
job type: Contract
salary: $38.26 - 53.57 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Monitor and ensure compliance with new and changing regulations.
- Collaborate with the USDA on regulatory approvals and import/export compliance.
- Act as a resource for customer regulatory and technical inquiries.
- Maintain the ISO 13485-based quality system.
- Implement and manage Corrective and Preventive Actions (CAPA) and problem resolution.
- Coordinate quality documentation, Nonconformance Reports, and inspection activities.
- Manage the review and revision of procedures, specifications, and forms.
- Manage new product setup and related projects.
- Create new product master files.
- Provide training on quality systems and regulations.
- Evaluate processes for improvements and standardization.
- Experience with 21 CFR 820 and ISO 13485.
- Experience with internal/external audits.
- Experience with Continuous Improvement, Lean, or Six Sigma.
- SAP, EtQ, or PeopleSoft experience.
- Statistical analysis.
- Project management.
- Knowledge of animal by-product import/export regulations, animal health, virology, immunology, or epidemiology.
- Bachelor's degree in a science or engineering field (Chemistry or Biology preferred).
- Minimum 3 years in Quality or Regulatory, preferably in the medical device, pharmaceutical, or biotechnology industries.
qualifications:
- Experience level: Experienced
- 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: 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 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.
