Director of Quality Engineering

Job Title: Director of Quality Engineering

Location: Irvine, CA (primarily on-site)

Job Summary:

We are seeking a highly skilled and experienced Director of Quality Engineering to lead our Quality Engineering team in ensuring the highest standards of quality for our medical device products, with a focus on spinal and orthopedic devices. The ideal candidate will have extensive experience in the medical device industry, specifically within the spinal or orthopedic sectors, and possess a strong background in quality engineering, regulatory compliance, and team leadership.

Key Responsibilities:

• Lead and mentor the Quality Engineering team, fostering a culture of quality, innovation, and continuous improvement.
• Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure quality is embedded throughout the product lifecycle.
• Develop and implement quality engineering strategies that align with company goals and regulatory requirements.
• Oversee the development, implementation, and maintenance of quality systems in compliance with ISO 13485, FDA QSR, and other relevant regulatory standards.
• Ensure that all products meet or exceed customer expectations and regulatory requirements.
• Lead the preparation for and participate in regulatory audits and inspections.
• Support product development teams by providing quality engineering expertise in design control, risk management, and process validation.
• Ensure that Design History Files (DHFs), Device Master Records (DMRs), and other quality documentation are complete, accurate, and compliant.
• Oversee the execution of process validation, verification, and qualification activities for new and existing products.
• Lead continuous improvement initiatives to enhance product quality, reduce defects, and improve operational efficiency.
• Utilize data-driven decision-making to identify trends, root causes, and opportunities for improvement.
• Implement corrective and preventive actions (CAPA) and monitor their effectiveness.
• Manage supplier quality activities, including supplier audits, performance evaluations, and development of supplier quality agreements.
• Work closely with suppliers to ensure the consistent delivery of high-quality components and materials.
• Oversee the development and maintenance of the company’s risk management processes, including FMEAs and risk assessments.
• Ensure that risk management activities are integrated into all stages of product development and manufacturing.

Qualifications:

• Bachelor’s degree in engineering or a related field. Advanced degree preferred.
• Minimum of 10 years of experience in Quality Assurance and Quality Engineering within the medical device industry, with a focus on Class II products and ideally orthopedics.
• Extensive knowledge of FDA regulations, ISO 13485, and other relevant standards.
• Proven experience in leading quality engineering teams and managing complex projects.
• Strong understanding of design control, process validation, and risk management in the context of medical devices.
• Excellent problem-solving skills and the ability to make data-driven decisions.
• Strong communication and interpersonal skills, with the ability to effectively collaborate across departments and with external stakeholders.
• Certification in quality management (e.g., CQE, CQA, Six Sigma) is highly desirable.