Quality Assurance Engineer

Hydrogen UK Ltd; Hayward (CA); Hybrid; USD 48,000 - 59,000; Part time

Job summary

Hydrogen UK Ltd is seeking a Quality Assurance Specialist to support manufacturing under regulatory standards in Hayward, CA. The role focuses on nonconforming material, RMA, deviations, CAPA, and documentation, with a 3‑month contract and hybrid onsite schedule (2 days/week on site).

The requirements include 0–3+ years in QA in a regulated setting, familiarity with 21 CFR 820 and ISO 13485, and CAPA/change control experience.

Responsibilities

• Provide key support for management of nonconforming material (NC), RMA, and deviations to ensure timely resolution of manufacturing interruptions.
• Develop SAP workflows for RMA and NCM handling.
• Execute usage decisions for RMA per QMS requirements.
• Verify accuracy and compliance of NC and deviation records.
• Plan and execute material containment, including holds and system transactions.
• Collaborate cross-functionally to implement process improvements and resolve material/process issues.
• Support global project implementations, including system testing and stakeholder communications.
• Ensure adequacy of nonconformance, deviation, and CAPA records and investigations.
• Familiarize with applicable tech to participate in risk-based decisions.
• Assist with material inspections when needed.
• Maintain company docs related to QA functions and forms.
• Promote a Zero Defect mentality throughout manufacturing.
• Provide logistics support for external audits.

Job description

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.