Quality Engineer I - San Diego, CA
Posted 5 days ago by 1755833315
Negotiable
Undetermined
Undetermined
San Diego, California
Summary: The Quality Engineer I role in San Diego, CA, involves executing quality system controls within SAP and supporting global Quality Management System initiatives. The position requires collaboration with stakeholders to ensure compliance with regulations and effective communication across sites. The contract duration is three months, with a focus on quality assurance in a regulated environment. Candidates should possess relevant experience and knowledge of quality regulations and standards.
Key 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.
Key Skills:
- 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.
Salary (Rate): £37.00 hourly
City: San Diego
Country: United States
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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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