Versa Vascular
Versa Vascular is an innovative medical device startup developing next-generation implantable solutions for the treatment of tricuspid heart valve disease. Our mission is to improve patient outcomes through precision engineering, rigorous quality standards, and collaborative innovation. We are seeking a detail-oriented
Quality Control Technician
to support in-process and final inspection of finished devices, labeling inspections, incoming inspection of purchased materials, and reviewing and filing quality records inspection. This role is essential to ensuring our products meet rigorous regulatory, quality system, and performance requirements while supporting rapid development in a collaborative startup environment.
Clean Room/Production responsibilities include:
Perform in-process quality inspections of implantable medical devices and delivery systems to ensure compliance with specifications and quality standards.
Verify and reconcile product labels for accuracy, completeness, and traceability.
Execute established test methods to assess product functionality and verify conformance to performance requirements.
Identify, document, and segregate nonconforming product, promptly communicating findings to the engineering team for evaluation and disposition.
Maintain adherence to clean room protocols, Good Manufacturing Practices (GMP), and all applicable quality system regulations.
IQC responsibilities include:
Conduct thorough visual and dimensional inspections of incoming materials, components, and associated documentation to verify compliance with specifications and quality standards.
Utilize appropriate measuring instruments, including Keyence measurement, visual systems, and hand tools to perform accurate inspections.
Record, analyze, and maintain inspection data and quality records in accordance with acceptance criteria.
Follow established sampling plans, inspection procedures, and Good Documentation Practices (GDP) to ensure consistency and traceability.
Identify, document, and segregate nonconforming materials; elevate quality issues to appropriate stakeholders for resolution.
Maintain organized inspection records and support continuous improvement of inspection processes.
Other quality responsibilities include:
Review quality documents (Device History Records, Nonconforming Reports, Calibration reports, Manufacturing records, etc.) for completeness and compliance to procedures.
File and maintain quality records.
Skills:
Demonstrated knowledge of Metrology and Inspection Technique.
Ability to use hand tools, calibrated instruments, measurement equipment, microscopes, and testing fixtures.
Ability to work independently.
Proficiency with written and spoken English.
Ability to use Microsoft Office applications.
Requirements:
High school diploma or equivalent.
Minimum of 3 years of experience in a quality control role; experience in the medical device industry preferred.
Experience and comfortable working in a cleanroom manufacturing environment.
Basic understanding of Quality System Regulation.
Ability to prioritize and organize work independently.
Flexible and comfortable in a fast-paced work environment.
No medical conditions preventing access to a Controlled Environment Room.
DHR (Device History Record) review experience is a plus.
Why Join Us
We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like. We enjoy time inside the office and out!
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.
Apply Today! We look forward to hearing from you.
#J-18808-Ljbffr
Quality Control Technician
to support in-process and final inspection of finished devices, labeling inspections, incoming inspection of purchased materials, and reviewing and filing quality records inspection. This role is essential to ensuring our products meet rigorous regulatory, quality system, and performance requirements while supporting rapid development in a collaborative startup environment.
Clean Room/Production responsibilities include:
Perform in-process quality inspections of implantable medical devices and delivery systems to ensure compliance with specifications and quality standards.
Verify and reconcile product labels for accuracy, completeness, and traceability.
Execute established test methods to assess product functionality and verify conformance to performance requirements.
Identify, document, and segregate nonconforming product, promptly communicating findings to the engineering team for evaluation and disposition.
Maintain adherence to clean room protocols, Good Manufacturing Practices (GMP), and all applicable quality system regulations.
IQC responsibilities include:
Conduct thorough visual and dimensional inspections of incoming materials, components, and associated documentation to verify compliance with specifications and quality standards.
Utilize appropriate measuring instruments, including Keyence measurement, visual systems, and hand tools to perform accurate inspections.
Record, analyze, and maintain inspection data and quality records in accordance with acceptance criteria.
Follow established sampling plans, inspection procedures, and Good Documentation Practices (GDP) to ensure consistency and traceability.
Identify, document, and segregate nonconforming materials; elevate quality issues to appropriate stakeholders for resolution.
Maintain organized inspection records and support continuous improvement of inspection processes.
Other quality responsibilities include:
Review quality documents (Device History Records, Nonconforming Reports, Calibration reports, Manufacturing records, etc.) for completeness and compliance to procedures.
File and maintain quality records.
Skills:
Demonstrated knowledge of Metrology and Inspection Technique.
Ability to use hand tools, calibrated instruments, measurement equipment, microscopes, and testing fixtures.
Ability to work independently.
Proficiency with written and spoken English.
Ability to use Microsoft Office applications.
Requirements:
High school diploma or equivalent.
Minimum of 3 years of experience in a quality control role; experience in the medical device industry preferred.
Experience and comfortable working in a cleanroom manufacturing environment.
Basic understanding of Quality System Regulation.
Ability to prioritize and organize work independently.
Flexible and comfortable in a fast-paced work environment.
No medical conditions preventing access to a Controlled Environment Room.
DHR (Device History Record) review experience is a plus.
Why Join Us
We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.
We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off.
We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like. We enjoy time inside the office and out!
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.
Apply Today! We look forward to hearing from you.
#J-18808-Ljbffr