Manager, Medical Device Quality Systems

Manager, Medical Device Quality Systemsis responsible forsupporting the implementation, maintenance, continuous improvement, and global scaling ofCognixionsquality management system for its medical devices and research products. This role delivers regulatory and quality subject matterexpertiseto internal stakeholders, supports readiness for and engagement with external regulators and auditors, and program-manages cross-functional initiatives to drive process improvement and QMS globalization.

Duties andresponsibilities

• Host external audits and serves as the primary QMS representative,demonstratingcompliance with ISO 13485 and applicable country-specific medical device requirements to regulators, notified bodies and other auditing organizations.
• Plan and conducts internal audits to evaluate QMS conformity and effectiveness against ISO 13485 and other applicable regulatory requirements, and to verify implementation across functions.
• Lead audit response activities, including root cause investigations, corrective action planning, and effectiveness verification, in collaboration with process owners and cross-functional subject matter experts.
• Maintains workingexpertisein current and emerging medical device regulations, standards, and guidance documents relevant toCognixionsproducts and markets.
• Performs regulatory and QMS compliance assessments to inform critical business decisions (e.g. product changes, market expansion, supplier strategy, system/tooling adoption).
• Analyzes and trends QMS performance metrics and prepares/communicates inputs to Top Management for management review, including risks,opportunitiesand recommended actions.
• Program-manage cross-functional initiatives to strengthen, scale and continually improve the QMS, including harmonization/globalization efforts and process optimization.
• Creates, co-creates and guides implementation of QMS processes, procedures, and records to ensure consistent, audit-ready execution across the organization.

Qualifications

• Bachelors degree, preferably in engineering, physical science, life science, or pharmacy. Minimum of 8 years relevant industry experience in a regulated environment.
• ISO 13485 Lead Auditor certification byprofessionalbody isrequired.
• Preferred credentials: CMQ-OE, Six Sigma Black Belt Certification, PMP
• Regulatory inspection experience preferably with direct agency inspector interaction.
• Strong project management skills.
• Demonstrated understanding of quality assurance, quality control, regulatory, manufacturing, and principles of validation in regulated environments.
• Strong project management skills.
• Demonstrated leadership skills, such as relationship building, influence at all levels of the organization, teamwork, sound judgement, and stakeholder management.