Quality Engineer

SCIENTIA VASCULAR INC•West Valley City, UT

25d

About The Position

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. This position 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, this 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.

Requirements

BA/BS degree in a Life Science, Engineering, Physical Science, a related field of study 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 as to 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

Responsibilities

Work closely with cross-functional partners to ensure product design conforms to internal specifications, customer, and regulatory requirements in order 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, opportunities may exist to mentor or manage a limited number of technicians, interns, or other more 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 to all applicable standards
Design and qualify inspection test methods and equipment.
Act as direct support for Transfer Engineers during process development and process transfer into production
Update and assist in the generation of the PFMEA risk documentation
Own and support Nonconformance Report investigations and any 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
Ensures the company is in a constant state of readiness for FDA, ISO, and customer audits
Other duties as assigned with or without accommodation