Quality Engineer II

Quality Engineer II

Location: Fremont, CA 6months W2 contract with high possibility of extension based on performance and depending on business needs. Pay Range: $34 to $40/Hour on W2

The Quality Engineer is a key technical member of the Quality Engineering organization responsible for ensuring product and process quality, regulatory compliance, and effective execution of Quality Management System requirements throughout the product lifecycle. This position partners cross-functionally with Manufacturing, Engineering, R&D, Quality Control, Regulatory Affairs, Supply Chain, and other functions to prevent and resolve quality issues, assess product and process risk, support new products and changes, investigate nonconformances and deviations, execute CAPAs, support controlled-substance/DEA compliance activities, and drive continuous improvement. The Quality Engineer applies risk-based thinking, data analysis, and structured problem-solving to identify root causes and implement sustainable solutions that improve product quality, process performance, and the effectiveness of the Quality Management System.

Product & Manufacturing Quality

• Provide day-to-day Quality Engineering support to other functions.
• Partner with other functions to identify, investigate, and resolve product and process quality issues.
• Evaluate manufacturing and quality data to identify adverse trends, recurring issues, and opportunities for improvement.
• Provide Quality input into process improvements and ensure appropriate controls are established and maintained.
• Support product disposition and evaluation of potentially nonconforming product as appropriate.
• Participate in Gemba and other floor-based Quality activities to proactively identify risks and improvement opportunities.
• Ensure Quality Engineering activities comply with applicable procedures, cGMP requirements, and Quality Management System requirements.

Nonconformance, Deviations & Investigations

• Lead and/or support investigations of nonconformances, deviations and other product or process quality events.
• Perform product-impact and risk assessments and support appropriate containment and disposition decisions.
• Apply structured problem-solving/root cause analysis methodologies such as 8D, Fishbone, 5-Why and other appropriate investigation tools.
• Partner with investigation owners and subject matter experts to determine true root cause and develop effective corrective actions and preventive actions, as applicable.
• Ensure investigations are technically sound, appropriately documented, and completed within established timelines.
• Analyze recurring events and trends to identify opportunities for systemic corrective action.

CAPA

• Initiate, lead and/or support Corrective Action and Preventive Action (CAPA) investigations.
• Develop and implement appropriate corrective and preventive actions with cross functional CAPA team based on investigation findings into established root cause and risk.
• Support development and execution of effectiveness checks to verify actions have sustainably addressed identified causes.
• Provide Quality Engineering input during CAPA reviews and cross-functional problem-solving activities.
• Monitor CAPA and investigation data for systemic trends and opportunities for improvement.

Risk Management

• Conduct, review, and update product and process risk assessments in accordance with applicable procedures and standards.
• Support and maintain risk-management documentation throughout the product lifecycle.
• Facilitate or participate in DFMEA, PFMEA and other risk-analysis activities.
• Ensure risks identified through complaints, nonconformances, deviations, CAPAs, manufacturing data and product changes are appropriately evaluated.
• Use field and manufacturing data, where applicable, to support occurrence estimates and ongoing risk evaluation.
• Ensure risk controls are appropriately implemented and verified.

Design, NPI & Change Control

• Provide Quality Engineering support for new product development, new product introduction, design transfer, and product lifecycle activities.
• Participate in design and technical reviews to ensure Quality and regulatory requirements are appropriately addressed.
• Support design controls and ensure identified product and process risks are appropriately addressed throughout development and transfer.
• Review and approve validation/qualification protocols and reports, as applicable.
• Provide Quality Engineering assessment of product, process, and manufacturing changes.
• Support Engineering Change Orders (ECOs), Product/Process Change Orders (MOCs), and other applicable change-control processes.
• Ensure changes are appropriately evaluated for Quality, regulatory, validation, and risk-management impact.

Complaints & Post-Market Quality

• Provide technical Quality Engineering support for customer complaint investigations supporting cross functional SMEs.
• Partner with appropriate functions to investigate product performance and manufacturing-related complaint issues.
• Ensure complaint findings are evaluated for potential relationships to nonconformance, CAPA and product risk.
• Analyze complaint and product-performance data for recurring trends and opportunities for corrective action.
• Support field-action investigations and related risk assessments when required.

Continuous Improvement & Quality Metrics

• Identify and lead projects that improve product quality, process capability, and Quality System effectiveness.
• Use KPIs, Quality metrics, and statistical methods to identify trends and prioritize improvement opportunities.
• Partner with other functions to reduce defects, scrap, rework, nonconformances, and other sources of poor quality.
• Participate in Practical Process Improvement (PPI), Lean and other continuous-improvement activities.
• Provide Quality Engineering data and analysis for Quality reviews, Management Review, and other business forums.
• Track assigned actions and projects to completion and proactively escalate barriers or risks.

Audit & Regulatory Support

• Maintain inspection readiness within assigned areas of responsibility.
• Support internal Quality audits and external customer, notified-body, and regulatory inspections.
• Provide technical information and documentation during audits and inspections as requested.
• Support investigation and remediation of audit observations applicable to assigned areas.
• Maintain compliance with applicable Quality Management System requirements, ISO standards, GMP and regulatory requirements.

Controlled Substances / DEA Compliance

• Support and maintain compliance with applicable controlled-substance and DEA requirements for products and site activities within assigned areas of responsibility and escalating to controlled area coordinator/management as needed.

Education

• Bachelor's degree in Engineering, Chemistry, Biology, Biotechnology, Life Sciences or another related scientific/technical discipline.
• Advanced degree may substitute for a portion of required experience where appropriate.

Experience

• 2–5 years of relevant Quality Engineering, Quality Assurance, Engineering, or related experience in a regulated industry.
• Experience in medical devices, in vitro diagnostics, pharmaceutical, biotechnology, or another regulated manufacturing environment preferred.

Knowledge, Skills & Abilities

• Working knowledge of applicable cGMP, ISO 13485, FDA Quality Management System requirements like QMSR, IVDD, IVDR and other applicable regulatory requirements.
• Working knowledge of Quality Management Systems including nonconformance, deviation, CAPA, complaint, change control and risk management.
• Experience applying structured problem-solving and root-cause-analysis techniques.
• Knowledge of product and process risk-management tools, including FMEA.
• Experience with validation and qualification activities preferred.
• Ability to analyze manufacturing and Quality data, identify trends, and translate findings into actions and improvements.
• Working knowledge of statistical Quality techniques and process monitoring preferred.
• Strong technical writing and documentation skills.
• Strong analytical, critical-thinking, and decision-making capabilities.
• Ability to independently manage multiple priorities while meeting established timelines.
• Strong interpersonal skills and demonstrated ability to work effectively with cross-functional teams.
• Ability to communicate technical Quality issues clearly to both technical and non-technical stakeholders.
• Experience with electronic Quality Management and enterprise systems such as MasterControl, Oracle, or equivalent preferred.
• Proficiency with Microsoft Office applications.
• ASQ CQE/CQA, Lean or Six Sigma certification preferred.
• Knowledge of or experience with controlled-substance/DEA regulatory requirements and compliance processes preferred.
• Ability to analyze technical product formulation and composition information to support controlled-substance determinations and regulatory documentation.
• Ability to interpret and apply regulatory and Quality Management System requirements to product and process decisions.

These requirements combine the existing QE I foundation—analytical/problem-solving capability, Quality Systems, documentation, audit support, and continuous improvement