Sr Quality Engineer

Position Summary

We are seeking an experienced Quality Engineer to support Post-Market Quality Engineering activities within a highly regulated environment. This role is responsible for ensuring product quality, regulatory compliance, and continuous improvement throughout the product lifecycle. The Quality Engineer will partner closely with Quality, Manufacturing, Regulatory Affairs, R&D, Operations, Supplier Quality, and Customer Service teams to investigate quality issues, drive corrective and preventive actions (CAPA), maintain risk management documentation, and support post-market surveillance activities.

The ideal candidate will have a strong background in quality engineering, root cause analysis, risk management, and quality systems within the medical device, pharmaceutical, biotechnology, diagnostics, or other regulated industries.

Join us in Northridge, CA, a vibrant community known for its dynamic work environment and commitment to innovation. This location offers the perfect blend of professional growth opportunities and a high quality of life.

Key Responsibilities

Post-Market Quality Support

• Support post-market quality activities to ensure ongoing product safety, effectiveness, and compliance with applicable regulations and standards.
• Review, analyze, and trend post-market data, including complaints, nonconformances, customer feedback, field performance data, and adverse event information.
• Collaborate with cross-functional teams to investigate product quality issues and identify appropriate corrective actions.
• Support complaint investigations and product performance assessments as required.

CAPA Management

• Lead and support Corrective and Preventive Action (CAPA) activities from initiation through closure.
• Conduct root cause investigations using structured problem-solving methodologies such as 5 Why, Fishbone Analysis, Fault Tree Analysis, and DMAIC.
• Develop, implement, and verify effectiveness of corrective and preventive actions.
• Ensure CAPA documentation is complete, accurate, and compliant with quality system requirements.

Risk Management

• Maintain and update risk management documentation throughout the product lifecycle.
• Participate in risk assessments and risk reviews using methodologies such as FMEA, Hazard Analysis, and Risk-Benefit Analysis.
• Support risk evaluations resulting from complaints, nonconformances, CAPAs, design changes, supplier issues, and field actions.
• Ensure alignment of risk management activities with applicable regulatory and quality requirements.

Quality Systems & Compliance

• Support compliance with applicable regulatory standards including FDA Quality System Regulations, ISO 13485, ISO 14971, GMP, and company quality procedures.
• Participate in internal audits, external audits, and regulatory inspections.
• Support change control activities and assess quality impacts of proposed changes.
• Review and approve quality documentation including procedures, reports, investigations, validation documents, and risk assessments.

Data Analysis & Continuous Improvement

• Analyze quality metrics and identify trends to proactively address potential product or process issues.
• Develop and present quality performance reports to management and cross-functional stakeholders.
• Participate in continuous improvement initiatives to enhance product quality, reliability, and process effectiveness.
• Support implementation of quality improvement projects and best practices.

Cross-Functional Collaboration

• Work closely with Manufacturing, Engineering, Regulatory Affairs, Clinical, Operations, Supplier Quality, and Customer Service teams to resolve quality issues.
• Provide quality engineering support for product changes, investigations, and improvement initiatives.
• Facilitate effective communication of quality-related risks, issues, and resolutions across the organization.

Required Qualifications

• Bachelor's degree in Engineering, Quality, Biomedical Engineering, Mechanical Engineering, Industrial Engineering, Chemical Engineering, or related technical discipline.
• 4-10 years of Quality Engineering experience in a regulated industry.
• Experience supporting post-market quality, complaint handling, CAPA, and risk management activities.
• Strong understanding of quality systems and regulatory requirements.
• Experience performing root cause investigations and implementing corrective actions.
• Knowledge of risk management methodologies including FMEA and risk assessment tools.
• Experience working within cross-functional teams in a manufacturing or product development environment.
• Strong analytical, problem-solving, and technical writing skills.
• Excellent verbal and written communication skills.

EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.