Software Quality Engineer - Medical Device

We are seeking a highly skilled and detail-oriented Software Quality Engineer specializing in medical devices to join our innovative team. The ideal candidate will possess a comprehensive understanding of quality assurance principles within the medical device industry, ensuring that products meet stringent regulatory standards and quality benchmarks. As a Software Quality Engineer, you will be responsible for developing, implementing, and maintaining quality systems that uphold the safety, efficacy, and compliance of our medical software solutions. Your expertise will contribute to advancing healthcare technology through rigorous testing, analysis, and continuous improvement initiatives.

Software Quality Engineer Responsibilities

• Develop and execute comprehensive quality assurance plans aligned with regulatory standards such as FDA regulations, ISO 9001, and ISO.
• Conduct thorough quality audits and inspections to verify adherence to GMP (Good Manufacturing Practices), HACCP (Hazard Analysis Critical Control Point), and CGMP (Current Good Manufacturing Practices).
• Lead root cause analysis and problem-solving activities related to software defects, non-conformities, or process deviations using Six Sigma methodologies.
• Collaborate with cross-functional teams including engineering, manufacturing, and regulatory affairs to ensure compliance with quality standards in production.
• Implement and monitor quality control procedures for software validation, verification, and risk management processes such as GD&T (Geometric Dimensioning & Tolerancing).
• Maintain detailed documentation of quality metrics, audit findings, and corrective actions to support regulatory submissions and internal reviews.
• Facilitate training sessions on quality systems, regulatory compliance standards, and best practices in manufacturing environments.
• Lead continuous improvement initiatives utilizing Lean management principles to enhance efficiency and product reliability.

• Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Quality Assurance, or a related field; advanced certifications such as CQE (Certified Quality Engineer) are preferred.
• Proven experience practicing in an industrial or manufacturing engineering role within the medical device sector or regulated manufacturing environment.
• Strong knowledge of regulatory/legal compliance standards including FDA regulations, ISO 9001, GMP, HACCP, CGMP, and related quality standards.
• Expertise in conducting quality audits and implementing quality management systems aligned with ISO.
• Familiarity with Six Sigma manufacturing techniques and tools for process optimization.
• Proficiency in quality inspection methods including GQ/D&T (Geometric Quality/Dimensioning & Tolerancing) analysis skills.
• Excellent communication skills for effective cross-functional collaboration and team leadership.
• Demonstrated ability to analyze complex data sets to identify trends and drive corrective actions.

Join us in shaping the future of healthcare technology by ensuring the highest standards of software quality in medical devices!, * Bachelor’s (Required)

Experience:

• Software Quality Engineer: 1 year (Required)

Ability to Commute:

• Carlsbad, CA 92011 (Required)

Pulled from the full job description 401(k) Health insurance Vision insurance Dental insurance, * 401(k)

• Dental insurance
• Health insurance
• Vision insurance