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: 3 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:
Responsibilities:
- Provide ongoing quality engineering support throughout the product life cycle.
- Provide support to manufacturing functions for validation planning and transfer activities.
- Ensures adequacy of non-conformances and CAPA records, investigations, and corrective actions.
- Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
- Review equipment onboarding, calibration and preventative maintenance tickets and identify potential gaps for GMP compliance.
- Review change requests/notices/approvals for compliance to change requirements outlined in applicable WIs/Procedures.
- Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
- Coordinate issue resolution using a risk-based approach.
- Ensure manufacturing processes meet requirements of FDA and ISO.
- Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis.
- Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
- Collaborate with counterparts and cross-functional teams at other Illumina sites.
- Other activities as assigned.
#LI-JW1
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: 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.
