Quality Assurance Manager

• Support the QMS Management Representative by:
• Ensuring processes needed for the quality management system are documented.
• Reporting to top management on the effectiveness of the QMS and any need for improvement.
• Ensuring the promotion and awareness of applicable regulatory and QMS requirements throughout the organization.

• Collaborate with departmental leaders to maintain quality procedures supporting VahatiCor's product development, manufacturing, and regulatory activities.

• Collaborate with departmental leaders to maintain quality procedures supporting VahatiCor's product development, manufacturing, and regulatory activities.
• Participate in management review activities and track identified quality system improvement actions.

• Partner with R&D to ensure efficient and compliant Quality System procedures for Product Development, Life Cycle Management, and Software Quality are established.

• Partner with R&D to ensure efficient and compliant Quality System procedures for Product Development, Life Cycle Management, and Software Quality are established.
• Work with R&D teams to ensure product design projects are executed in accordance with regulatory requirements and VahatiCor's design control procedures.
• In partnership with R&D, ensure compliance with the most current ISO 14971 requirements throughout the product lifecycle.
• Ensure all quality and regulatory-driven requirements for products and services in intended markets are mapped into product specifications and are traceable.
• Write and review protocols and reports, FMEAs, Design Verification and Validation documentation, Control Plans, Software Development strategies, plans and reports, and Process Validation protocols and reports.
• Collaborate with Regulatory Affairs to ensure technical documentation supports applicable FDA submissions, clinical-stage development activities, and future commercialization requirements.

• Support the QMS Management Representative by:
• Ensuring processes needed for the quality management system are documented.
• Reporting to top management on the effectiveness of the QMS and any need for improvement.
• Ensuring the promotion and awareness of applicable regulatory and QMS requirements throughout the organization.

• Collaborate with departmental leaders to maintain quality procedures supporting VahatiCor's product development, manufacturing, and regulatory activities.

• Collaborate with departmental leaders to maintain quality procedures supporting VahatiCor's product development, manufacturing, and regulatory activities.
• Participate in management review activities and track identified quality system improvement actions.

• Partner with R&D to ensure efficient and compliant Quality System procedures for Product Development, Life Cycle Management, and Software Quality are established.

• Partner with R&D to ensure efficient and compliant Quality System procedures for Product Development, Life Cycle Management, and Software Quality are established.
• Work with R&D teams to ensure product design projects are executed in accordance with regulatory requirements and VahatiCor's design control procedures.
• In partnership with R&D, ensure compliance with the most current ISO 14971 requirements throughout the product lifecycle.
• Ensure all quality and regulatory-driven requirements for products and services in intended markets are mapped into product specifications and are traceable.
• Write and review protocols and reports, FMEAs, Design Verification and Validation documentation, Control Plans, Software Development strategies, plans and reports, and Process Validation protocols and reports.
• Collaborate with Regulatory Affairs to ensure technical documentation supports applicable FDA submissions, clinical-stage development activities, and future commercialization requirements.

• Provide input into the development of inspection plans, quality agreements, and supplier agreements, with particular emphasis on Design Transfer.

• Provide input into the development of inspection plans, quality agreements, and supplier agreements, with particular emphasis on Design Transfer.
• Collaborate with Manufacturing and Engineering to ensure approved design specifications, inspection requirements, manufacturing procedures, and quality acceptance criteria are appropriately transferred into production activities.
• Participate in quality reviews of contract manufacturers, suppliers, and associated manufacturing processes, including supplier audits and corrective actions as appropriate.
• Review manufacturing and process validation documentation for consistency with quality system procedures and regulatory requirements.

• Apply proactive, systematic problem-solving methodologies to identify, prioritize, and resolve product quality issues.

• Apply proactive, systematic problem-solving methodologies to identify, prioritize, and resolve product quality issues.
• Perform failure analysis by collaborating with Quality, Engineering, R&D, and Manufacturing on investigations.
• Define and monitor Product Development and Life Cycle Management metrics to drive product and process improvements.
• Effectively communicate progress, consistently drive solutions where necessary, and escalate issues requiring attention in a timely manner and with a sense of urgency.
• Coordinate nonconformance investigations and corrective and preventive action (CAPA) activities, including root cause analysis, implementation of corrective actions, and effectiveness verification.
• Identify recurring quality issues and recommend improvements to product specifications, processes, procedures, and quality controls.

• Manage and develop Product Quality, Quality Systems, and Quality Engineering resources.

• Manage and develop Product Quality, Quality Systems, and Quality Engineering resources.
• Establish priorities, coordinate assignments, and provide technical guidance and professional development to quality personnel.
• Promote collaboration among Quality, R&D, Regulatory, Manufacturing, and Clinical teams to address quality requirements and resolve issues.

• Lead preparation activities for Premarket Approval (PMA) Pre-Approval Inspection readiness.

• Lead preparation activities for Premarket Approval (PMA) Pre-Approval Inspection readiness.
• With the QMS Management Representative, lead the efforts of the PMA Pre-Approval Inspection front-room activities.
• Collaborate with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to ensure inspection-related documentation is complete, accurate, organized, and readily available.
• Participate in internal and external quality audits, coordinate responses to findings, and track corrective actions to completion.

• 10+ years of experience in Product Quality, Quality Engineering, a technical field, or an engineering field, including at least three years in the medical device industry.

• 10+ years of experience in Product Quality, Quality Engineering, a technical field, or an engineering field, including at least three years in the medical device industry.
• Five years of experience in a managerial role.
• Direct experience with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 compliance.
• Expertise in the development, validation, and manufacture of medical devices.
• Demonstrated ability to work effectively within a fast-paced, dynamic team environment.
• Ability to negotiate and influence key stakeholders and regulatory agencies to ensure compliance with regulatory requirements and business needs.
• Experience with medical device design controls, risk management, design verification and validation, process validation, and design transfer.
• Experience preparing for or participating in quality system audits and regulatory inspections.
• Ability to review complex technical documentation, identify compliance risks, and collaborate with cross-functional teams to resolve quality issues.

• Experience with Class III medical devices, particularly catheter-based cardiovascular technologies.

• Experience with Class III medical devices, particularly catheter-based cardiovascular technologies.
• Experience supporting PMA submissions or FDA PMA Pre-Approval Inspections.
• Experience in an early-stage or growing medical device company.
• Experience working with contract manufacturers and external suppliers.

• Bachelor's degree in Engineering, a technical field, or a related discipline.

• Bachelor's degree in Engineering, a technical field, or a related discipline.

• Leadership: Creates a vision for a company, function, or department that defines high expectations and standards of performance. Demonstrates the ability to engage and influence others toward common objectives, establish priorities, promote excellence, and encourage appropriate risk-taking and professional growth.
• Management: Sets clear objectives, allocates resources, communicates expectations, measures performance, provides constructive feedback, and develops employees. Ensures people understand both their responsibilities and how their contributions support organizational goals.
• Respect for the Individual: Treats others with integrity, fairness, empathy, and respect. Encourages diversity, candid communication, recognition of contributions, and an understanding of different perspectives.
• Innovation and Continuous Improvement: Demonstrates a commitment to continuous learning and the implementation of better methods, tools, and practices. Uses facts and data to identify organizational gaps, develop improvement plans, and reduce unnecessary work and inefficiencies.
• Customer Focus: Understands and responds to the expectations of internal and external customers. Builds