Senior Manager, Post Market Surveillance

Job Locations US-CA-Redwood City
Job Post Information* : Posted Date 1 week ago(9/16/2022 11:56 AM)
ID
2022-3844
Category
Quality

About Nevro

Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. The company is focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment.

 

We started with a simple mission to help more patients suffering from debilitating pain and developed our 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

 

In this highly visible role reporting to the Director of Post Market Quality, you will manage a team responsible for assuring compliance with US and international regulations and post market surveillance requirements for all Nevro sites. Working closely with Quality, R&D, Operations, and the Clinical & Medical Affairs teams, you will drive the process of monitoring and communicating the safety and efficacy of Nevro products.  You will therefore have the opportunity to be principal in ensuring Nevro’s Quality at the highest levels.

 

  • Recruit, hire, develop, and manage the teams and individual staff members to deliver customer experience excellence, compliance with regulations and meet requirements of internal stakeholders.
  • Manage all processes and systems in the department to ensure compliance and continuation of departmental operations. Ensure that outputs of the process and systems are delivered to the stakeholders in a timely manner.
  • Seek efficiency and/or optimization of time, resources, and cost for the department operations. Promote employee participation and leadership of process improvements in their functional area.
  • Initiate and execute projects based on assigned goals as well as on immediate opportunities for improvement.
  • Provide input in the planning and budgeting process for the department.
  • Collaborate with pre-market quality teams to support closed-loop initiatives and transfer newly released products into the Post Market quality team.
  • Collaborate with cross functional teams for project execution. Collaborate with stakeholders and team members to complete other deliverables in quality System like CAPA, NCR, recalls, risk and Impact Analysis, etc.
  • Monitor complaint adequacy, accuracy, and details to ensure conversion of data into good quality information for internal stakeholders and regulators.
  • Generate information from the data gathered from the Post Market Quality activities as per procedures and process. Lead the Post Market Surveillance and relevant safety report meetings as per regulations.
  • Participate in Quality Management Reviews by providing the data and attending meetings as necessary.
  • Participate in all internal and external audits to represent the Post Market Quality Department. Ensure audit results are formally recorded and reported and corrective and preventive actions are documented.
  • Write and maintain SOPs, WI’s, audit reports and other documentation as required. Ensure that all procedures and Work Instructions are updated, approved and that employees complete all work-related training in a timely manner.
  • Research latest standards and industry practices in the Post Market Quality function and recommend changes to process based on feedback to ensure that all processes within the department are compliant and up to date with the latest standards and technology.
  • Highly developed written and oral communication skills, with the ability to interpret data and information to generate solutions for improvement.
  • Must have good problem-solving skills and be able to work independently

Role Requirements

  • Bachelor’s degree in science or engineering required; advanced degree preferred.
  • Ten (10) or more years of directly related experience, with at least five (5) of those years in a class II or III medical device environment

Skills and Knowledge

  • Demonstrated experience managing direct reports, including recruiting, developing, coaching, and team building.
  • Ability to communicate well with all levels of staff and present data to Management when needed.
  • Strong technical capability, verbal and written communications skills and effective interpersonal skills.
  • Strong organizational and presentation skills. Ability to multitask, prioritize and meet deadlines.
  • Ability to analyze data, create reports from this analysis, and chart trends.
  • Direct experience creation and implementation of quality processes and procedures as they relate to the FDA Quality System regulations part 820, ISO 13485, MDD, EU MDR and other relevant country regulations.
  • Experience with electronic systems such as Pilgrim, Arena, EtQ, MasterControl preferred.
  • Practical applications of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans.
  • Proficient with Microsoft Office software: Word, Excel, Visio, PowerPoint.

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