Quality Assurance Manager

T45 Labs • Santa Clara, CA

24d • Onsite

About The Position

VahatiCor is a venture-backed medical technology company developing a cardiovascular therapy and building the quality systems and infrastructure needed for its next stage of growth. The Quality Assurance Manager is a hands-on management role within the Quality Department, overseeing inspectors and quality engineers and supporting the Quality Management System (QMS). The role focuses on Class III catheter-based cardiovascular technologies, including design controls, product development, risk management, manufacturing quality, design transfer, and regulatory inspection readiness.

The manager ensures QMS processes are documented and effective, communicates improvement needs to top management, and promotes awareness of regulatory and quality requirements across the organization. The role partners with R&D, Regulatory Affairs, Manufacturing, Engineering, and Clinical teams to establish and maintain compliant procedures, technical documentation, product quality controls, and regulatory readiness.

The position is onsite at VahatiCor's headquarters in Santa Clara, California. The anticipated hiring range is $127,000–$150,000. Candidates must be permanently authorized to work in the United States without current or future visa sponsorship. Relocation may be considered, with limited assistance potentially available.

Requirements

• At least 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 in a fast-paced, dynamic team environment.
• Ability to negotiate with and influence key stakeholders and regulatory agencies to meet 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 cross-functionally to resolve quality issues.
• Bachelor's degree in Engineering, a technical field, or a related discipline.
• Permanent authorization to work in the United States without current or future visa sponsorship.

Nice To Haves

• 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.
• Current residence within a reasonable commute of the Santa Clara office; candidates willing to relocate may also be considered.

Responsibilities

• Support the QMS Management Representative by ensuring required QMS processes are documented, reporting on QMS effectiveness and improvement needs, and promoting awareness of regulatory and QMS requirements.
• Collaborate with departmental leaders to maintain quality procedures supporting product development, manufacturing, and regulatory activities.
• Participate in management reviews and track quality system improvement actions.
• Partner with R&D to establish compliant Quality System procedures for product development, lifecycle management, and software quality.
• Ensure product design projects follow regulatory requirements and design control procedures, and support compliance with current ISO 14971 requirements throughout the product lifecycle.
• Ensure quality and regulatory requirements for products and services in intended markets are mapped into product specifications and traceable.
• Write and review protocols and reports, FMEAs, design verification and validation documentation, control plans, software development strategies and reports, and process validation documentation.
• Collaborate with Regulatory Affairs on technical documentation for FDA submissions, clinical-stage development, and future commercialization.
• Provide input on inspection plans, quality agreements, supplier agreements, and design transfer.
• Work with Manufacturing and Engineering to transfer approved design specifications, inspection requirements, manufacturing procedures, and acceptance criteria into production.
• Participate in quality reviews of contract manufacturers, suppliers, and manufacturing processes, including supplier audits and corrective actions as appropriate.
• Review manufacturing and process validation documentation for consistency with quality procedures and regulatory requirements.
• Apply systematic problem-solving methods to identify, prioritize, and resolve product quality issues; collaborate on failure analysis and investigations.
• Define and monitor product development and lifecycle management metrics to drive product and process improvements.
• Communicate progress, drive solutions, and escalate issues requiring attention in a timely manner.
• Coordinate nonconformance investigations and CAPA activities, including root cause analysis, corrective action implementation, 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; establish priorities, coordinate assignments, and provide technical guidance and professional development.
• Promote collaboration among Quality, R&D, Regulatory, Manufacturing, and Clinical teams to address quality requirements and resolve issues.
• Lead preparation for PMA Pre-Approval Inspection readiness and, with the QMS Management Representative, lead PMA Pre-Approval Inspection front-room activities.
• Ensure inspection documentation is complete, accurate, organized, and readily available in collaboration with relevant teams.
• Participate in internal and external quality audits, coordinate responses to findings, and track corrective actions through completion.

Benefits

• Limited relocation assistance may be available.
• Additional compensation elements such as bonuses, equity, and benefits may be considered as part of the total rewards package.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager