Title:
Quality Assurance Specialist
Pay:$35.00-$43.00/hour
Location:
Hayward, CA
Duration:
3-month contract
Schedule:
Monday–Friday, 8:00 AM–5:00 PM, Hybrid (Onsite 2 days/week, any days)
Responsibilities:
- Provide key support for the management of nonconforming material (NC), RMA, and deviations to ensure timely and efficient resolution of manufacturing interruptions and/or component quality issues.
- Develop subject matter expertise in SAP workflows for RMA and NCM handling.
- Execute usage decisions for RMA in accordance with QMS requirements.
- Verify the accuracy and compliance of NC and deviation records.
- Plan and execute all aspects of material containment, including physical and system transactions and management of holds.
- Collaborate as part of cross-functional teams to implement process improvements and/or resolve material or process issues.
- Support global project implementations, including system testing and local stakeholder communications.
- Ensure adequacy of nonconformance, deviation, and CAPA records, investigations, and corrective actions.
- Become familiar with applicable technology to facilitate participation in technical discussions and risk-based decision-making.
- Assist with material inspections as needed.
- Maintain company documentation related to assigned functions, including work instructions and forms.
- Promote a “Zero Defect” mentality throughout the manufacturing process.
- Provide logistics support for external audits.
- Perform other activities as assigned.
Requirements:
- 0–3+ years of experience in Quality Assurance supporting manufacturing in a regulated environment. Equivalent manufacturing experience with a demonstrated quality mindset may substitute.
- Experience applying quality regulations and standards, such as 21 CFR 820 and ISO 13485, to actual situations.
- Practical experience with design controls, risk management, validation, and/or change control desired.
- Experience with CAPA and failure investigation tools and techniques desired.
- Ability to adapt to a fast-paced, dynamic work environment with shifting demands.
- Strong verbal and written communication skills, with the ability to work effectively with diverse groups and function independently with limited direct supervision.
Education:
- Bachelor’s degree, ideally in an engineering discipline.
...