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job summary:
we are looking for a Data Quality Analyst for a client of ours in San Diego, CA. This will be a onsite role. So, we are looking for local candidates.1-3 years experience in a quality field within a regulated environment; direct experience working in in-vitro diagnostic manufacturing and design controls is preferred.
location: SAN DIEGO, California
job type: Contract
work hours: 8am to 4pm
education: Bachelors
responsibilities:
Review and assess device master records (DMRs) for completeness
Develop, deliver, and drive global QMS projects (transition, due diligence, integration) to ensure compliance to applicable regulations and standards
Utilize best practice problem solving (8D, Ishikawa, 5 Whys, etc.) to ensure goals are met
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 consult on QMS project/quality plans, risk assessments and remediation plans
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
qualifications: