QA Engineer - SHL Medical - North Charleston, SC

Location: Charleston, South Carolina, US

Reporting to: Quality Manager

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Quality Engineer position would support, oversighting process transfer, launch, scale up, manufacture, and post-market of SHL product to assure SHL quality high standards and compliance with applicable requirements, regulations and SOP’s.

Collaborates with regional and global counterparts to ensure consistency of critical processes. Effectively works with local, regional, and global employees to ensure regulatory compliance and SHL standards maintained across different sites.

Main Responsibilities
• Team member representing Quality on product transfer activities, providing quality insight on change control, validation of equipment and processes, and during product life cycle.
• Support the development and launch of new equipment for manufacturing processes.
• Review product performance using statistics tools to identify trends focusing on customer keeping a risk based thinking to prevent quality issues.
• Support investigation of observed nonconformities during manufacturing process.
• Support Non-conformity Material Review Board.
• Stablish product inspections processes to assure sampling plans and procedures are align to customer’s needs.
• Support test methods developm