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Director, Quality Operations

Company: Nevro
Location: Redwood City
Posted on: August 7, 2022

Job Description:

About Nevro

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 80,000 patients globally.

Nevro's comprehensive HFX--- spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy. Senza -, Senza II -, and Senza Omnia--- are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro's unique support services provide every patient with an HFX Coach--- throughout their pain relief journey and every physician with HFX Cloud--- insights for enhanced patient and practice management.

Job Summary & Responsibilities

This position is responsible for the management and enhancement of the quality system, collaborating with all departments within the company to ensure compliance to process/procedures related to Supplier Management/Monitoring, CAPA, Non-Conformance, Sustaining Engineering Projects, and Process Controls. This position reports to Vice President, Global Quality Systems.

  • Develops and implements the quality strategy throughout the organization. Helps create a quality focus culture through collaboration, training, metrics, and risk-based approach.
  • Executing and implementing enhancements to existing process in a manner that effectively supports the growth of the business.
  • Responsible to provide regular updates to Nevro Senior and Executive Management on any trends or corrective actions required.
  • Builds strategic partnerships with internal and external stakeholders to further departmental and organizational objectives.
  • Provide direction to employees and direct reports regarding processes related to Supplier Management/Monitoring, Risk Management, CAPA, Non-Conformance and Process Controls.
  • Work with supply chain to ensure quality/regulatory requirements are aligned in Quality Agreements, and Supply Agreements.
  • Ensure implementation of quality engineering practices across the sustaining engineering products to ensure product quality meets regulatory and customer expectations to include but not limited to: risk management, software quality assurance, process validation and process controls.
  • Lead employees in driving continuous improvement in department processes and establishing departmental objectives to meet functional goals.
  • Responsible/ championing on execution of quality related projects within the department and across departments.
  • Responsible for leading and managing Supplier Management program.
  • Ensure compliance with Nevro procedures and applicable regulatory requirements. Participate as required in FDA and notified body inspections and internal audits.
  • Provide support for maintaining QSR, GLP, GMP and FDA compliance standards and keeping up to date on current regulations and industry standards.
  • Demonstrates effective change leadership.
  • Lead other tasks as assigned.
    Role Requirements
    • A minimum of 15 years of experience in medical device with a working knowledge of appropriate FDA and European Regulatory requirements. Active Implantable Device experience and/or FDA class Ill devices preferred.
    • Must demonstrate a hands-on leadership ability to create a high-performing team.
      Skills And Knowledge
      • Direct experience maintaining procedures as they relate to the FDA Quality System regulations part 820 and ISO 13485 required.
      • Understand and working knowledge of EN ISO 14971, EN ISO 11135, EN ISO 10993, ASTM D4169, FDA Software Guidance, Cybersecurity guidance or similar standards.
      • Demonstrated experience working directly with customers to resolve quality concerns
      • Practical applications of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans.
      • Ability to analyze data, create reports from this analysis, and chart trends.
      • Strong technical capability, verbal and written communications skills and effective interpersonal skills;
      • Strong organizational and presentation skills.
      • Expert level knowledge of root cause analysis techniques and corrective action.
      • Hands on experience working with suppliers to improve quality.
      • Knowledge of lean principles (Green or Black belt certification a plus).
      • Ability to communicate well with all levels of staff and present data to Senior Management when needed.
      • Demonstrated experience leading diverse teams in a dynamic environment required
      • Demonstrated experience managing direct reports, including recruiting, developing, coaching, and team building.
      • Ability to thrive in a fast-paced, multidisciplinary environment.
      • Requires the ability to travel approximately 15% of the time throughout the United States and internationally.

Keywords: Nevro, Redwood City , Director, Quality Operations, Executive , Redwood City, California

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