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Head of Quality Assurance Engineering

2 months ago

Irvine, California, United States BioTalent Full time

Position: Director of Quality Engineering - Orthopedic Division

Location: Primarily on-site in Irvine, CA

Overview:

BioTalent is in search of a seasoned Director of Quality Engineering to spearhead our Quality Engineering division, ensuring that our medical device offerings, particularly in spinal and orthopedic solutions, meet the highest quality standards. The successful candidate will bring a wealth of experience from the medical device sector, especially in orthopedics, along with a robust foundation in quality engineering, regulatory adherence, and leadership.

Key Responsibilities:

  • Guide and develop the Quality Engineering team, promoting a culture centered on quality, innovation, and ongoing enhancement.
  • Work collaboratively with interdisciplinary teams, including Research & Development, Manufacturing, and Regulatory Affairs, to integrate quality throughout the product development process.
  • Formulate and execute quality engineering strategies that align with organizational objectives and compliance mandates.
  • Supervise the establishment, execution, and upkeep of quality systems in accordance with ISO 13485, FDA QSR, and other pertinent regulatory frameworks.
  • Guarantee that all products fulfill or surpass customer expectations and regulatory stipulations.
  • Lead the preparation for and engage in regulatory audits and assessments.
  • Assist 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 avenues for enhancement.
  • Implement corrective and preventive actions (CAPA) and evaluate their effectiveness.
  • Manage supplier quality processes, including supplier evaluations, performance assessments, and the formulation of supplier quality agreements.
  • Collaborate closely with suppliers to ensure the reliable delivery of high-quality components and materials.
  • Oversee the development and maintenance of the company's risk management protocols, including FMEAs and risk assessments.
  • Ensure that risk management practices are woven 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, with a concentration on orthopedics.
  • In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards.
  • Demonstrated experience in leading quality engineering teams and managing intricate projects.
  • Strong comprehension of design control, process validation, and risk management in the medical device context.
  • Exceptional problem-solving abilities and a capacity for data-driven decision-making.
  • Excellent communication and interpersonal skills, with the capability to effectively collaborate across various departments and with external partners.
  • Certification in quality management (e.g., CQE, CQA, Six Sigma) is highly advantageous.