Head of Quality Engineering

2 weeks ago

Irvine, California, United States BioTalent Full time

Position: Director of Quality Engineering - Ortho

Location: Irvine, CA (primarily on-site)

Overview:

BioTalent is in search of a highly qualified and seasoned Director of Quality Engineering to spearhead our Quality Engineering division. This role is crucial in maintaining the utmost quality standards for our medical device offerings, particularly in the spinal and orthopedic sectors. The successful candidate will possess significant experience in the medical device arena, especially within the orthopedic field, along with a robust background in quality engineering, regulatory adherence, and leadership.

Key Responsibilities:

  • Guide and nurture the Quality Engineering team, promoting a culture centered on quality, innovation, and ongoing enhancement.
  • Engage with cross-functional teams, including Research & Development, Manufacturing, and Regulatory Affairs, to ensure quality is integrated throughout the product lifecycle.
  • Formulate and execute quality engineering strategies that align with organizational objectives and regulatory mandates.
  • Supervise the creation, implementation, and upkeep of quality systems in accordance with ISO 13485, FDA QSR, and other pertinent regulatory standards.
  • Guarantee that all products fulfill or surpass customer expectations and regulatory standards.
  • Lead the preparation for and participate in regulatory audits and inspections.
  • Support product development teams by offering quality engineering insights in design control, risk management, and process validation.
  • Ensure that Design History Files (DHF), Device Master Records (DMR), and other quality documentation are thorough, precise, and compliant.
  • Oversee the execution of process validation, verification, and qualification activities for both new and existing products.
  • Drive continuous improvement initiatives aimed at enhancing product quality, minimizing defects, and boosting operational efficiency.
  • Utilize data-driven methodologies to identify trends, root causes, and areas for enhancement.
  • Implement corrective and preventive actions (CAPA) and monitor their effectiveness.
  • Manage supplier quality functions, including supplier audits, performance assessments, and the establishment of supplier quality agreements.
  • Collaborate closely with suppliers to ensure the consistent provision of high-quality components and materials.
  • Oversee the development and maintenance of the organization's risk management processes, including FMEAs and risk assessments.
  • Ensure that risk management practices are integrated into all phases of product development and manufacturing.

Qualifications:

  • Bachelor's degree in engineering or a related discipline; advanced degree preferred.
  • A minimum of 10 years of experience in Quality Assurance and Quality Engineering within the medical device sector, focusing on orthopedics.
  • Comprehensive knowledge of FDA regulations, ISO 13485, and other relevant standards.
  • Demonstrated experience in leading quality engineering teams and managing intricate projects.
  • Strong understanding of design control, process validation, and risk management within the context of medical devices.
  • Exceptional problem-solving abilities and a capacity for data-driven decision-making.
  • Excellent communication and interpersonal skills, enabling effective collaboration across departments and with external stakeholders.
  • Certification in quality management (e.g., CQE, CQA, Six Sigma) is highly desirable.

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