Location:
San Diego, CA
Schedule:
Standard Office Hours
Duration:
3-Month Contract
Pay range:$32.00 - $37.00 per hour
Responsibilities:
- Execute quality system controls within SAP, supporting the release of raw materials, components, and finished products.
- Lead and support global Quality Management System (QMS) initiatives such as transitions, due diligence, and integrations to ensure compliance with applicable regulations and standards.
- Apply best-practice project management methods to meet or exceed established goals, objectives, and performance metrics.
- Collaborate with stakeholders to define project scope and objectives, ensuring alignment and technical feasibility.
- Build and maintain effective communication channels across sites to ensure consistency and alignment within the Quality organization.
- Partner with subject matter experts (SMEs) and stakeholders to validate ERP-related Quality requirements prior to configuration.
- Facilitate design reviews, providing input on key Quality decisions, processes, and ERP configurations. Provide guidance on QMS project planning, risk assessments, and remediation strategies.
- Use structured problem-solving methodologies to identify, prioritize, communicate, and resolve quality-related issues.
Requirements:
- 0–2 years of experience in quality assurance within a regulated environment; experience in in-vitro diagnostic manufacturing is preferred.
- Knowledge of quality regulations and standards, including 21 CFR 820, ISO 13485, ISO 14971, and IVDD.
- Experience implementing quality controls within an ERP system; SAP experience preferred.
- Strong communication, facilitation, and negotiation skills.
- Ability to adapt to a fast-paced, dynamic environment with shifting priorities.
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