Senior Manager, Quality Systems

The Senior Manager, Quality Systems is responsible for supporting the sustainment and continuous improvement of our quality management system in support of Nalu medical device products. The role accomplishes this responsibility by providing regulatory subject matter expertise to internal business partners, demonstrating Nalu quality management system compliance to external regulators, and performing program management of continuous process improvement & initiatives with other cross-functional Nalu team members. This is an onsite position located in Carlsbad, CA.

Responsibilities:

• Hosts External Audits, demonstrating Nalu quality management system compliance to external regulators for ISO 13485, 21 CFR 820, and other country-specific regulatory requirements.
• Conducts Internal Audits to assess the compliance of Nalu quality management system in accordance with ISO 13485, 21 CFR 820, and other country-specific regulatory requirements.
• Strong knowledge of Corrective Action System leading root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
• Responsible for Training Program and compliance to internal and external requirements.
• Oversee Document Control including change management process.
• Maintains expertise in both current and emerging regulations and standards impacting Nalu medical device products.
• Team member for regulatory compliance assessments to support the decision-making in critical business decisions, including Product Actions.
• Analyzes & interprets quality system performance metrics, presenting to Top Management as part of Management Reviews.
• Program manage initiatives intended to improve the Nalu quality management system.
  
  
  

Qualifications

• Bachelor’s degree, preferably in engineering, physical science (e.g. Chemistry), life science (e.g. Microbiology or Biology).
• Minimum of 8 years of industry experience in a medical device regulated environment.
• ISO 13485 Lead Auditor certification by a professional body is preferred.
• Quality Assurance, Quality Control, or Regulatory background in a medical device regulated environment is required.
• Thorough, documented understanding/knowledge of FDA 21 CFR 820 and ISO 13485 standard.
• Regulatory inspection experience preferably with direct agency inspector interaction.
• Strong project management skills.