Quality Engineer I
San Diego, CA
Schedule:
Standard Office Hours
Duration:
6-Month Contract
Pay Rate Range:$34.00/ph - $42.00/ph
Job Responsibilities:
In this role, you will manage and support various quality-related tasks within a regulated manufacturing environment. Key responsibilities include:
- Providing key support for the management of nonconforming material (NCM), returned material authorizations (RMA), and deviations to ensure timely and efficient resolution of manufacturing interruptions and/or component quality issues.
- Developing subject matter expertise in SAP workflows for RMA and NCM handling.
- Executing usage decisions for RMA in alignment with Quality Management System (QMS) requirements.
- Verifying the accuracy and compliance of NCM and deviation records.
- Planning and executing all aspects of material containment, including physical and system transactions and management of holds.
- Collaborating with cross-functional teams to implement process improvements and resolve material or process issues.
- Supporting global project implementations, including system testing and local stakeholder communications.
- Ensuring adequacy of nonconformance, deviation, and CAPA records, investigations, and corrective actions.
- Gaining familiarity with applicable technology to facilitate participation in technical discussions and risk-based decision-making.
- Assisting with material inspections as needed.
- Maintaining company documentation related to assigned functions (e.g., work instructions, forms).
- Promoting a “Zero Defect” mentality throughout the manufacturing process.
- Providing logistics support for external audits.
- Performing other tasks as assigned.
Knowledge & Skills:
- 0-3+ years of experience in Quality Assurance supporting manufacturing in a regulated environment (equivalent manufacturing experience with demonstrated quality mindset may substitute).
- Practical understanding of quality regulations and standards, such as 21 CFR 820 and ISO 13485, and their application to real-world situations.
- Preferred experience in design controls, risk management, validation, and/or change control.
- Familiarity with CAPA processes and failure investigation tools/techniques is desirable.
- Adaptability to a fast-paced, dynamic work environment with shifting priorities.
- Strong verbal and written communication skills.
- Ability to work effectively with diverse groups and independently with minimal supervision.
Education & Experience:
- Bachelor’s degree, ideally in an engineering discipline or High School Diploma.
- Business conditions may require reasonable accommodations to meet additional tasks and responsibilities.
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