Manager, Post-Market Quality

Company Overview:

Saluda is a global healthcare company that is redefining Spinal Cord Stimulation (SCS) therapy at the intersection of automated algorithms, real-time diagnostics, and ground-breaking clinical evidence. The Saluda difference is defined by Dose-Control Technology via measurement of physiological response.

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt. With the passion and energy of an accomplished team of seasoned experts, our focus is to revolutionize the standard of care in the neuromodulation space by transforming the lives of patients suffering from debilitating pain.

The Role:

The Post-Market Quality Manager provides strategic and hands-on leadership for post-market quality activities supporting a Class III implantable spinal cord stimulation system in global markets. This role oversees complaint handling, investigations, vigilance activities, and integration of post-market outputs into the Quality Management System. The role leads a team of engineers, specialists, and technicians and partners closely with Regulatory Affairs, Quality, Marketing, and Field teams to ensure compliant reporting, support regulatory submissions and audits, and drive continuous improvement. The position reports to the Director of Quality and requires engaging regularly with executive leadership.

Responsibilities:

Lead and develop a post market quality team of engineers, specialists, and technicians, providing hands on guidance, coaching, and performance management in a highly regulated environment

Own and oversee the end to end complaint handling and investigation process for a Class III implanted medical device, including direct involvement in complex or high risk cases

Ensure timely, compliant, and high quality global vigilance and adverse event reporting in alignment with FDA, EU MDR, and Australian regulatory requirements

Drive effective root cause analysis, documentation quality, and escalation of safety, quality, and compliance issues arising from post market data

Ensure post market outputs are appropriately integrated into the Quality Management System, including trending, CAPA, risk management, and management review

Lead and support health hazard evaluations, field action assessments, and recall related activities as required

Partner closely with Regulatory Affairs to support regulatory submissions, post market surveillance deliverables (including PSURs), and responses to regulatory authority inquiries

Serve as the post market quality lead during internal, external, and regulatory audits, ensuring inspection readiness and effective issue resolution

Collaborate cross functionally with Supplier Quality, Design Assurance Quality, Operational Quality, Marketing, and Field teams to improve issue identification, data quality, and reporting timeliness

Drive continuous improvement of post market processes, tools, and team efficiency, addressing current pain points related to reporting timeliness, resource constraints, and team maturity

Requirements:

Bachelor’s degree in engineering or a scientific/technical discipline; engineering background preferred

Minimum of 5 years of post market quality experience in the medical device industry, with direct involvement in complaint handling and investigations for regulated products

Working knowledge of global post market and vigilance requirements, including FDA regulations, ISO 13485, and EU MDR, preferably for Class III or implantable medical devices

Demonstrated experience leading, mentoring, or supervising others, with the ability to work hands on while effectively managing priorities, timelines, and cross functional stakeholders

Saluda Medical embraces diversity and equal opportunity. We are committed to building a team representative of a variety of backgrounds, perspectives, and skills. We believe people are the source of our inspiration and innovation.

Saluda Medical does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Saluda Medical’s approved agency list. Unsolicited resumes or candidate information submitted to Saluda Medical by search/recruiting agencies not already on Saluda Medical’s approved agency list shall become the property of Saluda Medical.