Senior Manager, Post Market Surveillance

About MicroTransponder

MicroTransponder, Inc. is dedicated to transforming the lives of stroke survivors through its innovative neurostimulation technology. The company's flagship product, the FDA-approved Vivistim® Paired VNS™ System, enhances stroke rehabilitation by pairing vagus nerve stimulation (VNS) with physical and occupational therapy. This approach leverages the brain's neuroplasticity to improve upper limb function, offering new hope to those with chronic arm and hand impairments following an ischemic stroke.

By integrating this therapy into rehabilitation programs, MicroTransponder aims to help stroke survivors regain independence in daily activities and enhance their quality of life. The company's commitment to advancing stroke recovery is evident in its ongoing research and collaboration with healthcare providers to make this therapy accessible to more patients.

About the role

The Senior Manager Post Market Surveillance plays a pivotal role in ensuring quality and compliance of MicroTransponder products and services. This position is integral to upholding our values of people, service, quality, and innovation. By supporting the teams responsible for collection of customer feedback, product investigation and resolution of product quality issues, this team member ensures that our products consistently meet the highest standards, enhancing patient care and satisfaction.

In this role, you will oversee MicroTransponder’s Post Market Surveillance program, collect, triage, and process customer feedback and complaints and lead complaint investigations. Your expertise will be crucial in ensuring the continued quality of Vivistim.

What you'll do

• Manages Post Market Surveillance program, ensures collection and analysis of data required to determine opportunities for improvement, timely and accurate completion of post market reports.
• Manages complaint handling program and system, ensures efficient throughput of complaint intake, risk assignment, investigation, resolution and closure.
• Leads investigative teams to identify root cause of product and system issues.
• Assists with the analytical analysis of root cause issues ensuring a comprehensive understanding of the underlying causes and supports the implementation of corrective actions to prevent future occurrences, conduct independent investigations of issues, where appropriate.
• Reviews reported issues and complaints and escalates serious issues for Health Hazard
• Evaluation and Adverse Event reportability.
• Monitors and reports on product performance through post market KPIs and operational metrics to track progress and make data-driven decisions. 
• Provides leadership, guidance, and mentorship fostering a culture of collaboration, accountability, innovation, and continuous improvement.
• Supports quality initiatives such as developing and enforcing robust procedures, training, and mentoring staff on quality standards, utilizing data-driven approaches to identify and address root causes of quality issues.
• Provides support during audits and regulatory inspections.
• Provides backup and support for other QA functions as required.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Scientific or Technical discipline and years of progressive 10 years
• progressive experience; or equivalent combination of relevant experience and education.
• Minimum 5 years of experience in a quality role.
• Experience with international regulatory agencies with thorough knowledge of manufacturing/controls and current good manufacturing practices (cGMP).
• Experience, training, or certifications in quality engineering is desired.
• Thorough knowledge of new process development in accordance with FDA regulations and ISO requirements.
• Excellent communication and leadership skills.
• Ability to support a team of technical associates, managing projects, workload and resource requirements while supporting development of employees involved in post market surveillance activities.
• In-depth knowledge of national and international regulations applicable to medical devices for implantable medical devices including cGMP, Food Drug Administration regulations (21 CFR Parts 820) and ISO 13485:2016.
• Strong analytical and problem-solving skills.
• Strong drive to achieve results and meet com