Quality Assurance Manager

T45 Labs • Santa Clara, CA

10h • $127,000 - $150,000 • 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. The Quality Assurance Manager is a hands-on management role in the Quality Department, overseeing inspectors and quality engineers and supporting quality systems for Class III catheter-based cardiovascular technologies. The role emphasizes design controls, product development, risk management, manufacturing quality, design transfer, and regulatory inspection readiness.

The Manager supports the QMS Management Representative by ensuring processes are documented, reporting on QMS effectiveness and improvement needs, and promoting awareness of regulatory and QMS requirements. Working across R&D, Regulatory Affairs, Manufacturing, Engineering, Clinical, and other departments, the Manager helps ensure compliant product development and manufacturing practices, complete regulatory documentation, effective investigations and corrective actions, and preparation for PMA pre-approval inspections.

This is a full-time, exempt, onsite position at VahatiCor’s headquarters in Santa Clara, California. The position reports to the Chief Operations Officer • Manufacturing. 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. Candidates within a reasonable commuting distance are prioritized; 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 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.
• Bachelor’s degree in Engineering, a technical field, or a related discipline.
• Permanently authorized to work in the United States without the need for 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 commuting distance of the Santa Clara office; candidates willing to relocate may also be considered.

Responsibilities

• Ensure processes needed for the QMS are documented; report to top management on QMS effectiveness and improvement needs; and promote awareness of applicable 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 procedures for product development, life cycle management, and software quality, and ensure projects follow regulatory requirements and design-control procedures.
• Work with R&D to maintain compliance with current ISO 14971 requirements throughout the product lifecycle, and ensure applicable product and service requirements are mapped into specifications and traceable.
• Write and review protocols and reports, FMEAs, design verification and validation documentation, control plans, software development strategies and documentation, and process validation protocols and reports.
• Collaborate with Regulatory Affairs to ensure technical documentation supports FDA submissions, clinical-stage development, and future commercialization.
• Provide input on inspection plans, quality agreements, and supplier agreements, particularly for 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 QMS procedures and regulatory requirements.
• Use systematic problem-solving methods to identify, prioritize, and resolve product quality issues; collaborate across Quality, Engineering, R&D, and Manufacturing on failure analyses and investigations.
• Define and monitor product development and life cycle management metrics to drive product and process improvements; communicate progress, drive solutions, and escalate issues promptly.
• 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.
• Coordinate inspection documentation readiness with relevant teams; participate in internal and external audits, coordinate responses to findings, and track corrective actions through completion.

Benefits

• Potential additional compensation elements may include bonuses, equity, and benefits; specific benefits are not listed.
• Limited relocation assistance may be available.

What This Job Offers

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