Careers

Job Posted: 6/25/2025

Job Title: Quality Engineer
Reports to: Quality Manager

Summary:

As a Quality Engineer at Vascular Technology, Incorporated, you will work to improve the quality of products and processes while operating in a culture highly receptive to quality with the objective of doing the right thing. You will have the opportunity to support and provide guidance to the adherence of processes and procedures in order to maintain safety, efficacy and quality of our products and compliance with applicable standards and regulations.

Duties and Responsibilities:

• Assigned to processes and projects of moderate to high complexity, perform compliance assessments, make decisions regarding quality and regulatory requirements; ensures adherence to current regulations.
• Team participant assigned to projects related to quality initiatives and compliance improvements.
• Author new and revise existing operating procedures and test or inspection protocols and reports.
• Perform impact assessments, root cause analysis, identification and implementation of appropriate corrective actions and preventative actions.
• Perform statistical analysis/trend problem reporting data to support the site (e.g. yield improvements, CAPA, complaint and scrap reduction).
• Contribute to continual process improvement by participating in site projects.
• Facilitate risk assessments, FMEAs for new product introduction, and take appropriate actions during quality oversight activities to ensure adequate controls in relation to the level of product quality, safety and business risks.
• Create/maintain and/or remediate Design History Files and Risk Management Files.
• Perform Supplier Change Evaluations, Internal Change Evaluations, Product Quality Reviews, Customer Notifications, Field Action activities.
• Participate in new product development activities to ensure the smooth transfer from development to production.
• Support other activities within the Quality Management System as required.
• Other duties as assigned.

Preferred Qualifications:

• Working knowledge of industry standards (e.g. ISO 13485, ISO 14971, ISO 11135, ISO 60601, etc.) Ability to work independently or as part of a team, self- motivated, adaptable
• Excellent communication skills both verbal and written Strong attention to detail
• Proactive

Education/Experience:

Bachelor’s Degree in an Engineering discipline from an accredited college or university; and minimum four years’ experience in medical device industry or another highly regulated field; or equivalent combination of education and experience.

Knowledge, Skills and Other abilities:

• Knowledge of industry standards including ISO 13485 and ISO 14971 at minimum
• Knowledge of Food and Drug Administration Part 820
• Knowledge of EU MDD/MDR and other applicable country directives and regulations