Quality Assurance Manager

Position Overview

As a member of the Quality Department, the Quality Assurance Manager will oversee a team of inspectors and quality engineers. The Manager will support the Quality Management System (QMS) by ensuring processes are documented, updating top management on the effectiveness of the QMS and areas for improvement, and promoting quality policies throughout the organization. The Manager will partner with R&D and Regulatory teams to ensure procedures are compliant and accurately documented for regulatory submissions. This is a hands-on management role supporting VahatiCor's Class III catheter-based cardiovascular technologies, with particular emphasis on design controls, product development, risk management, manufacturing quality, design transfer, and regulatory inspection readiness.

Key Responsibilities

Quality Management System (QMS)

• Support the QMS Management Representative by ensuring processes needed for the quality management system are documented.
• Report to top management on the effectiveness of the QMS and any need for improvement.
• Ensure 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.
• Participate in management review activities and track identified quality system improvement actions.

Product Development, Design Controls, and Risk Management

• 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.

Manufacturing Quality, Supplier Quality, and 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.

Product Quality, Investigations, and Continuous Improvement

• 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.

Quality Leadership and Personnel Development

• 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.

Regulatory Inspections and PMA 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Education

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