Job Description

Title: Quality Manager - Engineering

Status: Full-time, Exempt

Reports to: Sr. Director of R&D

Our team is dedicated to developing technologies that will change the medical device landscape. If you are seeking an opportunity to make a real impact on patients’ lives and grow your career VahatiCor is the right place for you.

Role Summary

VahatiCor, a T45 Labs portfolio company, is seeking a highly motivated Quality Engineer to support the production of groundbreaking medical devices. This position is both strategic and hands-on, requiring leadership of the QA team, as well as expertise and direct involvement in catheter manufacturing, documentation development, process improvement, and risk assessment. This role will be responsible for creating and maintaining documents within our Quality System, including: Manufacturing Process Instructions (MPIs), work instructions, test methods, design verification (DV) protocols, and reports. The candidate will play a hands-on role in improving manufacturing workflows, developing fixtures, identifying process gaps, and optimizing testing procedures. The ideal candidate will thrive in a fast-paced startup environment, be an effective cross-functional collaborator, and have the entrepreneurial drive to make a measurable impact on patient lives.

Key Responsibilities

Quality Leadership & Strategy

• Lead and manage the QA team in the development, implementation, and daily execution of quality system policies, procedures, strategies, and documents.
• Oversee daily operations of the QA department, ensuring all activities align with business goals, customer requirements, and regulatory expectations.
• Provide leadership, training, and mentoring to QA staff to enhance team skills, foster collaboration, and drive results.
• Provide leadership, training, and mentoring to QA staff to enhance team skills, foster collaboration, and drive results.
• Work directly with product development and manufacturing to train and ensure QMS compliance.
• Perform internal and external supplier audits/inspections.
• Support combination product regulatory filings and clinical trials (US and OUS).
• Collect and report key quality metrics to management.

Documentation & Compliance

• Develop and maintain Quality System documentation including MPIs, SOPs, work instructions, test methods, protocols (DV), and validation reports.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, GMP, and ICH guidelines.
• Support combination product regulatory filings and clinical trials (US and OUS).
• Coordinate, review, and approve final sterile product lot release
• Perform and oversee internal and external audits, inspections, and supplier quality assessments.

Manufacturing & Process Improvement

• Partner with R&D, engineering, and manufacturing to integrate quality standards across the product lifecycle.
• Identify and fill gaps in manufacturing and documentation processes.
• Develop and refine workflows for manufacturing and testing, ensuring efficiency and compliance.
• Design and implement fixtures, tooling, and process improvements to enhance catheter production.
• Conduct root cause analysis and corrective actions (CAPA) to resolve quality issues.

Testing & Risk Assessment

• Lead the development and validation of test methods for catheter components and final assemblies.
• Conduct risk assessments (FMEA, hazard analysis) to proactively identify and mitigate quality risks.
• Collaborate with R&D, Manufacturing, and Regulatory teams to ensure product quality and reliability.
• Ensure all product releases meet defined quality criteria before market launch.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline; or equivalent technical background.
• 5+ years of experience in Quality within a regulated medical device industry (catheter or vascular device experience preferred).
• Minimum 2 years in a management/leadership role overseeing QA or Quality Engineering teams.
• Proven expertise with ISO 13485, FDA 21 CFR Part 820, GMP, and ISO 14971 risk management.
• Strong track record in process optimization, test method development, equipment validation, and regulatory compliance.
• Proficiency in developing MPIs, work instructions, test methods, protocols, and validation reports.
• Excellent leadership, organizational, and communication skills, with the ability to manage multiple priorities in a dynamic environment.
• Hands-on, startup mentality with a proactive approach to problem-solving and continuous improvement.
• Ability to work cross-functionally to identify and close process gaps.

Eligibility

Candidates must be legally authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor H-1B visas.

Location & Compensation

This position is onsite in our Santa Clara, CA office.

T45 Labs is committed to fair and equitable pay practices, and compensation may include bonuses, equity, and benefits as part of the total rewards package.

The anticipated salary range for this position is $142,000 - $192,000 annually, based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as experience, skills, and geographic location.

Equal Employment Opportunity Statement

T45 Labs and its affiliated companies are Equal Opportunity Employers. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs.

We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.

Third-Party Recruiter Notice

We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered property of T45 Labs and/or its affiliated companies, and no fees will be paid if the candidate is hired. If your agency or firm would like to officially submit candidates for any of our posted roles, please email careers@t45labs.com

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