Quality Assurance Inspector

Versa Vascular; Santa Cruz (CA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Equity participation

Comprehensive benefits

Career growth opportunities

Job summary

Versa Vascular is seeking a detail-oriented Quality Assurance Inspector to perform incoming, in-process, and final inspections of implantable devices, delivery systems, and purchased components. You will verify labeling, conduct testing, and review quality records in a fast-paced, onsite setting.

Join a startup environment focused on regulatory compliance and manufacturing quality, with opportunities to influence device history records and continuous improvement initiatives.

Qualifications

• High school diploma or equivalent.
• Minimum three years of experience in quality inspection or related manufacturing quality role; medical device experience preferred.
• Experience working in a cleanroom manufacturing environment.
• Basic understanding of FDA requirements and ISO 13485.
• Ability to prioritize work in a fast-paced environment.
• DHR (Device History Record) review experience is a plus.

Responsibilities

• Perform in-process and final inspections of implantable devices and delivery systems against approved specifications and acceptance criteria.
• Verify product labeling for accuracy, completeness, and traceability.
• Perform specified tests using approved methods and accurately document results.
• Identify, document, and segregate nonconforming product; raise issues for evaluation and disposition by authorized personnel.
• Follow applicable GMP and quality-system procedures and maintain traceability and documentation.

Skills

Metrology

Dimensional measurement

Attention to detail

English proficiency

MS Office

Education

High school diploma or equivalent

Tools

Keyence systems

Microscopes

Calibrated instruments

Hand tools

Job description

Reports to: Director of Quality Assurance

Workplace type: Onsite 5 days a week

Location: Santa Cruz, California (moving to Los Gatos, CA in Q1 2027)

Position Type: Full-time, On-site

Description

Versa Vascular is a medical device startup developing innovative implantable solutions for tricuspid heart valve disease. We are seeking a detail-oriented Quality Assurance Inspector to perform incoming, in-process, and final inspections of implantable devices, delivery systems, and purchased components. Responsibilities also include labeling verification, product testing, and quality-record review. This role supports product conformity, regulatory compliance, and manufacturing quality in a collaborative startup environment.

Clean Room Inspection:

• Perform in-process and final inspections of implantable devices and delivery systems against approved specifications and acceptance criteria.
• Verify product labeling for accuracy, completeness, and traceability.
• Perform specified tests using approved methods and accurately document results.
• Identify, document, and segregate nonconforming product; raise issues for evaluation and disposition by authorized personnel.
• Follow applicable cleanroom protocols, Good Manufacturing Practices (GMP), and quality-system procedures.

Incoming Inspection (IQC):

• Perform visual and dimensional inspections of incoming materials and components against approved specifications and inspection plans.
• Use Keyence optical measurement systems, microscopes, calibrated instruments, and hand tools as appropriate.
• Verify inspection equipment calibration or verification status before use and report discrepancies.
• Accurately document results, maintain traceability, and follow sampling plans and Good Documentation Practices (GDP).
• Identify and segregate nonconforming materials, escape quality issues, and support inspection-process improvements.

Other quality responsibilities include:

• Review assigned Device History Records (DHRs), manufacturing records, nonconformance reports, and calibration records for completeness, traceability, and procedural compliance.
• Identify and segregate documentation discrepancies.
• Maintain inspection and quality records in accordance with document-control and record-retention requirements.

Skills

• Knowledge of metrology, dimensional measurement, and inspection techniques.
• Proficiency with measurement instruments, microscopes, and testing fixtures.
• Strong attention to detail, organizational skills, and ability to work independently.
• Effective written and verbal communication skills in English.
• Proficiency with Microsoft Office applications.

Requirements

• High school diploma or equivalent.
• Minimum three years of experience in quality inspection, quality control, or a related manufacturing quality role; medical device experience preferred.
• Experience working in a cleanroom manufacturing environment.
• Basic understanding of medical device quality-system requirements, including applicable FDA requirements and ISO 13485.
• Ability to prioritize work and adapt to a fast-paced environment.
• Ability to meet applicable cleanroom gowning, hygiene, and access requirements, with reasonable accommodation as applicable.
• DHR (Device History Record) review experience is a plus.

Why Join Versa Vascular

• Help bring innovative structural heart therapies to patients with significant unmet clinical needs.
• Work alongside a highly experienced team of clinical, engineering, and cardiovascular experts.
• Influence clinical strategy and execution at a critical stage of company growth.
• Competitive compensation, equity participation, and comprehensive benefits.
• Collaborative culture that values innovation, ownership, and professional development.
• Opportunity to make a meaningful impact on the future of cardiovascular care.

Versa Vascular is an Equal Opportunity Employer and is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, gender identity, sexual orientation, or any other protected characteristic under applicable law.