Justin
Design Quality Assurance Engineer Ii @Candela Medical
Signup · Get unlimited contacts
WORK HISTORY
Design Quality Assurance Engineer Ii @Candela Medical
MA, US
Develop statistically sound sampling plans and perform data analysisParticipate in analysis of complaint and post market surveillance data and risk analysis to assist in the identification of potential product improvements based on sound engineering principles.Participate in Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects as they relate to Design Assurance and Complaint Review Board ProcessResponsible for the cooperation with internal and external customer and R&D team to resolve Development related product quality issues.Responsible for review of Product Development Reports and relevant data.Ensure FDA and other regulatory knowledge and experience is applied to risk assessmentsWork with manufacturing engineering to ensure necessary design controls are in place for design changes.Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485 and other national and international quality and regulatory requirements and standardsContribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance
EDUCATION
University of Massachusetts Lowell
Master of Science - MS, Engineering Management
Wentworth Institute of Technology
Bachelor's degree, Biomedical/Medical Engineering
SKILLS
ABOUT JUSTIN
I’m an experienced Quality Engineer with a background in Biomedical Engineering and Engineering Management, focused on building compliant, reliable products in highly regulated environments, and specializing in risk-based quality systems and regulated product development. My focus is to bring innovative solutions and utilize regulatory frameworks to ensure safety and efficiency to help improve our quality of life. I partner with engineering and cross-functional teams to drive design controls, risk management, improve QMS processes, and compliance across complex systems—ensuring products are safe, effective, and audit-ready while enabling efficient development.I currently work as a Design Quality Assurance Engineer II, supporting design controls, validation, leadership and training, cybersecurity, new product introduction, lifecycle and sustaining support, risk analysis, and compliance for complex medical technologies.I have experience creating and improving processes for supplier management, internal and external audits, as well as risk documentation. I hold a B.S. in Biomedical Engineering and am pursuing an M.S. in Engineering Management.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.