Quality Manager

Location: Remote | Travel: Approximately 10% 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 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 DISCLAIMER: VYLO and FiberSafe are trademarks or registered trademarks of InnoVoyce. All rights reserved. All other trademarks are the property of their respective owners. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation. #J-18808-Ljbffr