job summary: This position is responsible for participating in 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 Requirements: 0-2 years experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred. Knowledge and experience applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD). Knowledge and experience with instituting quality controls in an ERP system, SAP preferred. Highly effective communication, facilitation and negotiation skills. Adaptable to fast-paced, dynamic work environment with shifting demands. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Bachelor of Science Degree Required location: SAN DIEGO, California job type: Contract salary: $29.75 - 37.75 per hour work hours: 8am to 4pm education: Bachelors responsibilities: Responsibilities: Execute to quality system controls in SAP. Assist with release of raw material, component and final product through system controls in SAP. Develop, deliver, and drive global QMS projects (transition, due diligence, integration) to ensure compliance to applicable regulations and standards. Utilize best practice project management to ensure goals, objectives, and performance metrics are met and/or exceeded. Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility. Establish and maintain cross-site communication channels with Quality department stakeholders to assure Quality department alignment. Engage SMEs to validate (i.e. vet with SMEs, stakeholders, and key site Quality personnel) all Quality department ERP requirements before configuration. Host design reviews, specifically addressing key Quality decisions, processes, and ERP (and related) configurations. Advises and consults on QMS project/quality plans, risk assessments and remediation plans. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. #LI-JW1 qualifications: Experience level: ExperiencedMinimum 3 years of experienceEducation: Bachelors skills: ManufacturingQualityContinuous ImprovementISO 14971ISO 1348521CFR 820NonconformanceERP system 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.