Overview

InnoVoyce is seeking an experienced Quality Manager to lead key quality and post-market surveillance activities across our medical device portfolio.

This role will be responsible for the development, implementation, and continuous improvement of InnoVoyce’s post-market surveillance program while ensuring compliance with applicable global regulatory and quality requirements, including ISO 13485, FDA 21 CFR Part 820/QMSR, Health Canada, and EU MDR. 

The ideal candidate brings significant medical device quality experience, strong expertise in post-market surveillance and complaint handling, and the ability to translate complex clinical, technical, and regulatory information into clear recommendations. This individual will work cross-functionally to support product safety, performance, regulatory compliance, and continuous improvement throughout the product lifecycle.

Key Responsibilities

Post-Market Surveillance & Compliance

• Lead the development, implementation, and continuous improvement of the company’s post-market surveillance (PMS) program 
• Establish and maintain PMS plans, procedures, reports, and supporting documentation in accordance with applicable regulatory requirements 
• Monitor and analyze post-market data, including complaints, adverse events, product returns, service reports, customer feedback, literature, registries, and other relevant data sources 
• Identify, investigate, and evaluate emerging trends, safety signals, and potential product risks 
• Maintain awareness of evolving global regulatory requirements and industry expectations related to PMS and vigilance

Regulatory Reporting & Documentation

• Ensure appropriate escalation of significant safety or performance issues and support regulatory reporting activities, including vigilance and field safety reporting where applicable 
• Prepare and/or oversee Post-Market Surveillance Reports, Periodic Safety Update Reports (PSURs), trend reports, and other required regulatory documentation 
• Support the development and execution of Post-Market Clinical Follow-up (PMCF) activities, where applicable 
• Ensure controlled documentation and records are maintained throughout the product lifecycle

Complaint Handling, Risk Management & Quality Improvement

• Complete complaint handling activities to ensure complaint data are accurately categorized, investigated, trended, and incorporated into PMS activities 
• Partner with Risk Management to ensure post-market information is appropriately incorporated into product risk assessments and risk management files 
• Evaluate whether post-market information indicates the need for corrective and preventive actions, product changes, labeling updates, clinical follow-up, or other risk mitigation activities 
• Lead or participate in cross-functional investigations and improvement initiatives related to product safety and performance

Quality Systems & Product Support

• Oversee the Device History Record (DHR) review and approval process and complete applicable Quality Engineering requirements 
• Manage bioburden testing 
• Ensure sterilization testing is completed for applicable medical devices 
• Support internal and external audits and regulatory inspections related to post-market surveillance 
• Develop and maintain PMS procedures, work instructions, templates, and training materials 
• Establish appropriate PMS performance metrics and dashboards to monitor program effectiveness 
• Provide guidance and training to internal stakeholders on PMS requirements and processes

Cross-Functional Leadership & Reporting

• Conduct periodic reviews of PMS data and metrics and communicate findings, trends, and recommendations to senior management 
• Collaborate with cross-functional teams to investigate quality and safety issues and support improvement initiatives 
• Provide clear, data-driven recommendations based on technical, clinical, quality, and regulatory information

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Biomedical Engineering, Regulatory Affairs, Quality, or a related discipline; advanced degree preferred 
• 7+ years of medical device experience with significant experience in post-market surveillance, complaint handling, regulatory affairs, quality, or a related function 
• Demonstrated experience developing and managing PMS programs and documentation 
• Strong understanding of applicable global regulatory requirements and standards, including FDA requirements, EU MDR/IVDR, ISO 13485, ISO 14971, and applicable vigilance requirements 
• Experience with complaint trending, signal detection, risk management, and regulatory reporting 
• Experience working with cross-functional teams and influencing stakeholders in a matrixed organization 
• Experience with quality management systems and electronic complaint/PMS systems 
• Strong analytical, problem-solving, and critical-thinking skills 
• Excellent written and verbal communication skills 
• Strong attention to detail and ability to manage multiple priorities and deadlines 
• Ability to interpret complex technical, clinical, and regulatory information and translate it into clear recommendations

Preferred Qualifications

• Experience supporting medical devices marketed across multiple global regions 
• Experience with EU MDR/IVDR PMS and PMCF requirements 
• Experience with FDA Medical Device Reporting (MDR), Corrections and Removals, and trending requirements 
• Experience preparing for or supporting regulatory inspections and notified body audits 
• Experience with statistical analysis, signal detection, or data analytics 
• Experience managing or mentoring team members 
• RAC, ASQ, or other relevant professional certification