Quality Manager

SummaryWe are seeking an experienced and proactive Quality Assurance Manager to oversee the development, implementation, and management of our Quality Management System (QMS). This role is critical to ensuring compliance with regulatory requirements for medical device design and development and manufacturing in a growing organization. The successful candidate will lead efforts to build and refine our QMS, facilitate regulatory approvals, and promote a culture of quality across the organization.This role will also have a unique opportunity to design, implement, and manage new QMS operations for Kickr’s regulated clients. Key ResponsibilitiesQMS Development and Oversight:Build, implement, and maintain a robust QMS compliant with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.Revise and improve existing QMS processes, ensuring scalability and effectiveness.Prepare and lead Quarterly Quality Management Review meetings to ensure that Key Performance Indicators (KPI) are being tracked and met.Regulatory Compliance:Ensure the company meets all applicable regulatory requirements for medical devices, including ISO 13485, FDA QSR, and EU MDR.Prepare and lead internal and external audits, including inspections by regulatory bodies.Documentation and Process Management:Create, revise, and manage key quality documents, such as Standard Operating Procedures (SOP),forms, templates, risk management files, and design and document control records.Oversee the identification and management of Non-conforming product records (NCR) and Corrective and Preventative Action (CAPA) processes, ensuring timely resolution of complaints. Product Development Support:Ensure design and development engineering teams properly generate Design History Files (DHF), within the Kickr QMS process to ensure regulatory compliance through all product lifecycle stages.Manage design control activities, including verification, validation, and risk management per ISO 14971.Supplier Quality ManagementConduct supplier evaluations, audits, and performance reviews.Establish quality agreements and ensure supplier compliance with applicable standards.Collaborate with suppliers to resolve quality issues and implement corrective actions.Training and Leadership:Train and mentor team members on quality processes and regulatory compliance.Collaborate with cross-functional teams to embed quality in all aspects of operations.Manage and track all training records for the Kickr team.Continuous Improvement:Identify opportunities to streamline quality processes while maintaining compliance.Establish metrics and KPIs to monitor and improve QMS performance.QualificationsEducation and experienceBachelor’s degree in Engineering, Life Sciences, Quality Management, or a related field.Minimum of 5+ years of experience in quality assurance, preferably in the medical device industry.Proven track record in building and managing ISO 13485-compliant QMS systems.Technical SkillsStrong understanding of FDA 21 CFR Part 820, ISO 14971, ISO 9001 and other regulatory standards.Hands-on experience with design controls, risk management, and validation processes.Familiarity with eQMS tools and traceability systems.Leadership and Soft SkillsExcellent attention to detail and problem-solving abilities.Strong communication and collaboration skills to work across departments.Ability to adapt processes for a small company environment while ensuring scalability.Preferred QualificationsCertification in Quality Management (e.g., CQE, CQA, or similar).Experience with global regulatory frameworks (e.g., EU MDR, Health Canada).Knowledge of statistical tools such as sample size power analysis, Design of Experiments (DOE), Gage Repeatability and Reliability (GRR), Six Sigma, or Statistical Process control (SPC).Experience with Minitab Statistical softwareCompensation Range100k - 150k