Head of Quality Assurance Engineering

2 weeks ago

Irvine, California, United States BioTalent Full time

Position: Quality Engineering Director

Location: Irvine, CA (primarily on-site)

Overview:

BioTalent is in search of a seasoned Quality Engineering Director to spearhead our Quality Engineering division, ensuring our medical device offerings, particularly in spinal and orthopedic fields, meet the utmost quality standards. The ideal candidate will bring a wealth of experience from the medical device sector, with a solid foundation in quality engineering, regulatory adherence, and team leadership.

Key Responsibilities:

  • Guide and develop 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 embed quality throughout the product lifecycle.
  • Formulate and execute quality engineering strategies that resonate with organizational objectives and regulatory mandates.
  • Supervise the establishment, execution, and upkeep of quality systems in alignment with ISO 13485, FDA QSR, and other pertinent regulatory frameworks.
  • Guarantee that all products fulfill or surpass customer expectations and regulatory standards.
  • Lead the preparation for and actively participate in regulatory audits and inspections.
  • Support product development initiatives by offering quality engineering insights in design control, risk management, and process validation.
  • Ensure completeness, accuracy, and compliance of Design History Files (DHF), Device Master Records (DMR), and other quality documentation.
  • Oversee the implementation of process validation, verification, and qualification activities for both new and existing products.
  • Champion continuous improvement projects aimed at enhancing product quality, minimizing defects, and boosting operational efficiency.
  • Leverage data-driven methodologies to pinpoint trends, root causes, and areas for enhancement.
  • Implement corrective and preventive actions (CAPA) and assess their effectiveness.
  • Manage supplier quality initiatives, including supplier audits, performance assessments, and the development of supplier quality agreements.
  • Collaborate closely with suppliers to ensure the reliable delivery of high-quality components and materials.
  • Oversee the formulation and maintenance of the organization's risk management protocols, including FMEAs and risk assessments.
  • Ensure that risk management practices are integrated throughout 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 industry, with a focus on Class II products, particularly in orthopedics.
  • Comprehensive knowledge of FDA regulations, ISO 13485, and other relevant standards.
  • Demonstrated experience in leading quality engineering teams and managing multifaceted projects.
  • Strong grasp of design control, process validation, and risk management within the medical device context.
  • Exceptional problem-solving abilities and a capacity for data-driven decision-making.
  • Excellent communication and interpersonal skills, facilitating effective collaboration across departments and with external partners.
  • Certification in quality management (e.g., CQE, CQA, Six Sigma) is highly desirable.

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