Director, Quality Operations
Location: Redwood City
Posted on: August 7, 2022
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
- Builds strategic partnerships with internal and external
stakeholders to further departmental and organizational
- 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
- 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
- Lead employees in driving continuous improvement in department
processes and establishing departmental objectives to meet
- Responsible/ championing on execution of quality related
projects within the department and across departments.
- Responsible for leading and managing Supplier Management
- 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.
- 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
Skills And Knowledge
- Direct experience maintaining procedures as they relate to the
FDA Quality System regulations part 820 and ISO 13485
- 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
- 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
- Hands on experience working with suppliers to improve
- Knowledge of lean principles (Green or Black belt certification
- 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
- Demonstrated experience managing direct reports, including
recruiting, developing, coaching, and team building.
- Ability to thrive in a fast-paced, multidisciplinary
- 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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