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Technical Director

3 months ago

Irvine, United States Skills Alliance Full time

Job Title: Technical Director

Location: Irvine, CA


A leading innovator in the medical device industry that is known for producing high-quality and reliable solutions to patients through their cutting-edge technology are looking for a Technical Director to join their team. They are looking for a highly experienced and strategic individual to lead their R&D as well as QARA functions.

The Technical Director will have a proven track record in the medical device industry, ensuring the highest standards of product quality and regulatory adherence. This role is crucial in driving our commitment to excellence and patient safety.


Key Responsibilities:

  • Develop, implement, and maintain robust quality management systems (QMS) in compliance with FDA, ISO 13485, and other applicable regulations and standards.
  • Develop and execute the R&D strategy, ensuring alignment with business goals and market needs
  • Oversee all aspects of product quality, from design and development through manufacturing and post-market surveillance.
  • Lead internal and external audits, inspections, and assessments to ensure compliance with regulatory requirements and internal policies.
  • Provide strategic direction and leadership in quality-related matters, contributing to overall business goals and objectives.
  • Mentor and develop team members, promoting professional growth and fostering a high-performance culture.
  • Some international and domestic travel is required


Qualifications:

  • Master’s degree in a medical-related field
  • Minimum of 10 years of experience within the medical device industry focusing on research and development, quality assurance, regulatory compliance
  • In-depth knowledge of FDA regulations, ISO 13485, ISO 14971 and other relevant quality standards.

Experience with Class III and Class II medical devices and implantable products desired.

  • Experience with direct contact with FDA and EU Notified Bodies
  • Experience managing cross-functional teams and complex projects.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively across all levels of the organization.


This is an opportunity to join a global organization who offer unrivalled career progression opportunities a highly attractive salary. Please either apply directly or send your resume to Akbar Ali, akbar.ali@skillsalliance.com for further information.