What are the responsibilities and job description for the Quality Engineer 1 position at Manpower San Diego?
- Develop global governance of quality system controls in SAP Establish and/or improve system controls in SAP for release of raw material, component and final product
- 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
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.
Salary : $30 - $37
