Lead Auditor for Internal Compliance

2 weeks ago


Fremont, California, United States NeuroTech X Full time
Position Title: Lead Auditor for Internal Compliance
Company: NeuroTech X
Location: Remote

Company Overview:

At NeuroTech X, we are pioneering advancements in brain-computer interface technology, developing innovative solutions aimed at empowering individuals with mobility challenges and enhancing human capabilities.


Department Overview:

Become a vital member of our Quality Assurance team, dedicated to upholding compliance with essential regulatory frameworks. Our team comprises seasoned professionals who leverage innovative thinking to create effective compliance systems. We aspire to establish internal quality benchmarks that surpass industry standards.


Key Responsibilities:
  • Execute comprehensive audits of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and engineering operations within NeuroTech X, ensuring alignment with regulatory mandates and internal policies.
  • Determine audit parameters and criteria, evaluate documentation, and interpret findings to gauge compliance levels. Offer constructive feedback and suggest corrective measures as necessary.
  • Conduct thorough root cause analyses to pinpoint compliance deficiencies and risks, presenting findings to management for appropriate action.
  • Champion process enhancements to improve systemic compliance and quality metrics, employing creativity and analytical skills.
  • Oversee the management of audit findings and deviations, ensuring effective resolution and timely completion of corrective actions.
  • Lead the coordination of external audits, including those conducted by regulatory bodies.

Qualifications:
  • Bachelor's degree in a relevant scientific or healthcare discipline.
  • A minimum of 4 years of auditing experience.
  • Proven experience in leading external audits.
  • Familiarity with GLP, GMP, and GCP auditing processes.
  • In-depth understanding of regulatory requirements and standards.
  • Strong analytical and quality assurance capabilities.
  • Exceptional communication and teamwork skills.
  • Experience in regulatory and technical documentation.

Preferred Qualifications:
  • Background in engineering.
  • Experience with international regulatory audits.
  • Familiarity with supplier auditing processes.

Compensation and Benefits:

NeuroTech X offers a competitive salary range, along with a comprehensive benefits package that includes:

  • Opportunities for professional growth and advancement.
  • Comprehensive medical, dental, and vision insurance.
  • Paid holidays and commuter benefits.
  • Meals provided during work hours.
  • Equity options and a 401(k) plan.
  • Parental leave and flexible time off.

NeuroTech X is committed to fostering a diverse and inclusive workplace. We encourage candidates from all backgrounds to apply, even if they do not meet every qualification listed.



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