Manager, Post-Market Quality
Saluda Medical
full-time
Posted on:
Location Type: Hybrid
Location: Minnetonka • Minnesota • United States
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About the role
- 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
Benefits
- Health insurance
- 401(k) plan
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
complaint handlinginvestigation processroot cause analysisdocumentation qualityCAPArisk managementhealth hazard evaluationsfield action assessmentspost market surveillanceregulatory submissions
Soft Skills
leadershipcoachingperformance managementcross functional collaborationissue resolutioncontinuous improvementmentoringprioritizationcommunicationteam management
Certifications
Bachelor’s degree in engineeringBachelor’s degree in scientific disciplineISO 13485 certification