Quality Assurance Manager
T45 Labs · Santa Clara, California, United States · onsite
QUALITY ASSURANCE MANAGER
Company: VahatiCor
Status: Full-time, Exempt
Location: Onsite, Santa Clara, CA
Reports to: Chief Operations Officer • Manufacturing
ABOUT THE COMPANY
VahatiCor is a venture-backed medical technology company developing a new cardiovascular therapy. As the company grows beyond its startup incubator, it is building the quality systems and infrastructure needed to support its next stage.
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.
- 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.
- 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,QUALITY ASSURANCE MANAGERCompany: VahatiCor
Status: Full-time, Exempt
Location: Onsite, Santa Clara, CA
Reports to: Chief Operations Officer • Manufacturing
ABOUT THE COMPANY
VahatiCor is a venture-backed medical technology company developing a new cardiovascular therapy. As the company grows beyond its startup incubator, it is building the quality systems and infrastructure needed to support its next stage.
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.
- 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.
- 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.
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