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Director of Quality Engineering

2 months ago

Irvine, United States BioTalent Full time

Job Title: Director of Quality Engineering - Ortho

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 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.