Quality Engineer

About Scientia Vascular

Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.

This position will work in all aspects of the Scientia Vascular Quality System with a primary focus on product quality assurance. They will work closely with all other departments to develop, implement, and monitor quality systems to deliver quality product to customers while maintaining regulatory compliance. The role has the necessary independence, authority, and responsibility to initiate action to prevent nonconformities, enact remediation plans, and proactively identify and document potential nonconformance issues.

Depending on experience, the position will work under general direction and have latitude in determining how to solve problems while maintaining focus on prevention, continuous improvement, and customer satisfaction.

• Work closely with cross‑functional partners to ensure product design conforms to internal specifications, customer, and regulatory requirements to ensure quality product.
• Provide quality guidance to manufacturing engineers, technicians, and product builders.
• Provide technical guidance to quality engineers, quality technicians, and inspectors; depending on experience, may mentor or manage a limited number of technicians, interns, or other junior engineers.
• Work closely with operations and quality personnel to monitor manufacturing processes.
• Partner with manufacturing engineering to review and investigate defects, perform root cause analysis, and develop and implement line improvements.
• Review designs, changes, and plans of specifications and processes.
• Develop and monitor quality data and metrics related to production.
• Assist in CAPA, complaint management, and medical device and vigilance reporting.
• Assist in all aspects of supplier management.
• Assist in internal and external audits.
• Lead and/or support projects to update and revise quality systems and procedures as necessary to meet the current needs of the organization while maintaining compliance with all applicable standards.
• Design and qualify inspection test methods and equipment.
• Act as direct support for transfer engineers during process development and transfer into production.
• Update and assist in the generation of the PFMEA risk documentation.
• Own and support nonconformance report investigations and related actions for NCRs generated in incoming or production spaces.
• Take action to maintain and improve product quality.
• Compile and present data for management review.
• Ensure the company is in a constant state of readiness for FDA, ISO, and customer audits.
• Other duties as assigned, with or without accommodation.

• BA/BS degree in a life science, engineering, or physical science field, or equivalent work experience and/or professional qualifications.
• Experience in a highly regulated industry.
• Knowledge and experience with quality systems, quality and manufacturing concepts, regulatory compliance requirements, and applied statistical concepts.
• Experience with medical device R&D, regulatory affairs, manufacturing or quality, preferably in or around a manufacturing environment.
• Ability to make sound decisions under pressure with reasonable foresight of outcomes.
• Good oral and written communication skills.
• Demonstrated knowledge of interpretation and application of QSR, MDD, EU MDR, ISO 13485, and other international standards.
• Demonstrated expertise in interpretation and pragmatic application of quality standards.
• Strong leadership ability, coupled with superior interpersonal, communication and influencing skills.
• Progressive leadership experience, including hands‑on quality systems development.

• Medical, dental, vision insurance.
• Generous paid time off (PTO).
• Paid parental leave.
• Paid holidays.
• 401(k) plan with a generous employer match.
• Life insurance (company paid).
• Short‑term and long‑term disability insurance (company paid).
• Subscription to
• Employee assistance program.
• An environment of belonging where everyone can thrive.

The Scientia Vascular culture is centered on the principals of equal opportunity for all employees. Consistent with our culture, all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, family status, marital status, sexual orientation, national origin, genetics, disability, age, veteran status, or any other non‑merit based or legally protected grounds.