Asks for

The ad says“Responsible for CAPA management from CAPA generation to implementation of corrective action, verification of effectiveness, and closure”
The ad says“Experience with design control is a must”
The ad says“Responsible for the Design History File, device Master Record and its maintenance”
The ad says“Responsible for the Design History File, device Master Record and its maintenance”
The ad says“Assists with internal audits. Assists with hosting external audits and drive all issues to closure if need be”
The ad says“Responsible for setting up the receiving inspection area, perform materials inspection such as incoming, First Article Inspection, and final product release”
The ad says“Assists with internal audits. Assists with hosting external audits and drive all issues to closure if need be”
The ad says“Applies regulatory requirements such QSR, MDR, ISO and generate procedures in compliance with regulations”
The ad says“Responsible for setting up the receiving inspection area, perform materials inspection such as incoming, First Article Inspection, and final product release”
The ad says“Applies regulatory requirements such QSR, MDR, ISO and generate procedures in compliance with regulations”
The ad says“Work with Product Development on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as creation of protocols and reports”
The ad says“Be able to coach others or teach the proper use of quality tools and problem solving techniques”
The ad says“Work with Product Development on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as creation of protocols and reports”
The ad says“Applies regulatory requirements such QSR, MDR, ISO and generate procedures in compliance with regulations”
The ad says“We are seeking a qualified individual to develop, implement, and maintain quality engineering methodologies, systems, and practices which meet Horizon Surgical Systems’s Quality and Regulatory requirements”
The ad says“Work with Product Development on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as creation of protocols and reports”
The ad says“Work with Product Development on the Risk Management Process and maintains the Risk Management File”
The ad says“Work with Product Development on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as creation of protocols and reports”
The ad says“Responsible for all supplier management activities including sourcing and qualifying suppliers, maintaining the Approved Suppliers List (ASL) and associated files, and managing the Supplier Corrective Action Request (SCAR) program”
The ad says“Work with Product Development on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as creation of protocols and reports”

We are seeking a qualified individual to develop, implement, and maintain quality engineering methodologies, systems, and practices which meet Horizon Surgical Systems’s Quality and Regulatory requirements
As a senior member of our team, you will provide quality engineering support in the design, development, and manufacturing of Horizon products to ensure that the products conform to established specifications and consistently meet or exceed the requirements of our customer and patients
Works with Product Development and Operations teams to establish quality requirements at all phases of product/process development and manufacturing
Work with Product Development on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as creation of protocols and reports
Work with Product Development on the Risk Management Process and maintains the Risk Management File
Responsible for the Design History File, device Master Record and its maintenance
Responsible for setting up the receiving inspection area, perform materials inspection such as incoming, First Article Inspection, and final product release
Responsible for documenting product discrepancies and follow up on NC implementation and closure
Responsible for all supplier management activities including sourcing and qualifying suppliers, maintaining the Approved Suppliers List (ASL) and associated files, and managing the Supplier Corrective Action Request (SCAR) program
Responsible for CAPA management from CAPA generation to implementation of corrective action, verification of effectiveness, and closure
Assists with internal audits. Assists with hosting external audits and drive all issues to closure if need be
Responsible for product packaging/labeling and ensuring all materials are conforming with applicable regulations
Other duties as assigned
This is an exciting opportunity to join a high-tech startup that is poised to revolutionize surgical robotics in ophthalmology

Preferred experience

We are seeking highly motivated, and intellectually inquisitive individuals looking to make a positive impact on healthcare via the development of robotic technology
Effective written and verbal communication and organizational skills
BS degree in Engineering, life sciences or related field – Advanced degree preferred
Applies regulatory requirements such QSR, MDR, ISO and generate procedures in compliance with regulations
Experience with software and firmware V&V is strongly preferred
Experience with design control is a must
Be able to coach others or teach the proper use of quality tools and problem solving techniques
Excellent people skills, team oriented
Excellent problem-solving skills
5 plus years experience as a Quality Engineer or in related field in the medical device Industry. ASQ CQE is a plus

Asks for

Values

Preferred experience