Open Position - Senior Quality EngineerHorizon Surgical Systems Inc.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.
Responsibilities & Duties- 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.
Required Qualifications- BS degree in Engineering, life sciences or related field - Advanced degree preferred.
- 5 plus years experience as a Quality Engineer or in related field in the medical device Industry. ASQ CQE is a plus.
- Experience with design control is a must.
- Experience with software and firmware V&V is strongly preferred.
- Applies regulatory requirements such QSR, MDR, ISO and generate procedures in compliance with regulations
- Excellent people skills, team oriented
- Excellent problem-solving skills
- Effective written and verbal communication and organizational skills
- Be able to coach others or teach the proper use of quality tools and problem solving techniques.
This is an exciting opportunity to join a high-tech startup that is poised to revolutionize surgical robotics in ophthalmology.
