Quality Assurance Engineer

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.

...