Quality Control Engineer

SHL Group; North Charleston (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

SHL Medical, a leading innovator in autoinjectors, is seeking a QC Engineer for its new North Charleston facility. You will support manufacturing automation and QC lab operations, developing work instructions and training materials while coordinating with metrology, testing, and transfer teams.

Ideal candidates have a bachelor’s degree in engineering or life sciences and 2+ years in the medical device arena, with strong communication and organizational skills and the ability to work across

Qualifications

• Bachelor’s degree in Engineering or Life Science.
• 2+ years in the medical device, pharmaceutical or biotechnology industry.
• Clear thinking with strong organization and communication skills.
• Ability to work cross-functional, inter-company and international.
• Experience writing work instructions, training material, and validation documentation.

Responsibilities

• Develop documentation for the QC Lab (work instructions, training materials).
• Train QC Inspectors on new test methods and equipment.
• Coordinate updates from Metrology, Testing and transfer teams.
• Review planned equipment for QC lab to meet SHL expectations.
• Attend planning meetings for New Products to understand QC testing plans.
• Coordinate calibration and preventive maintenance for new QC Lab equipment.
• Point of contact for QC Lab changes or needs.
• Manage all QC equipment and fixtures for QC lab testing.
• Perform other related duties as assigned.

Skills

Communication skills

Team player

Cross-functional

Organizational skills

Education

Bachelor’s degree in Engineering or Life Science

Tools

SAP

Job description

QC Engineer

Location: Charleston, South Carolina, US

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

This role is embedded in the Manufacturing Engineering group within our Global Operations Engineering team at our new state-of-the-art device manufacturing facility in North Charleston, South Carolina. Together, with the rest of the team, you will drive and support manufacturing automation, with a particular focus on our automated assembly equipment used for final production.

Main Responsibilities

• Develop documentation (work instruction, training material, etc.) for the QC Lab
• Train QC Inspectors to new test methods / equipment
• Liaison and receive test method / system updates from Metrology, Testing, and transfer team
• Review planned equipment for QC lab, ensure meets local SHL expectations, and will work in the QC Lab
• Attend Planning meetings for New Products to understand New Measuring Methods and plans for QC Testing
• Coordinate local support (calibration / preventive maintenance) for new QC Lab equipment
• Point of Contact for QC Lab for any upcoming changes or needs
• Identify problem statements and build relationship with external SHL support teams for issues related to internal systems (SAP, EiQMI, and MES)
• Manage all QC equipment and tool/fixtures to ensure QC Lab testing for production and validation actvties
• Performs other related duties as assigned.

Skills and Qualification

• Bachelor’s degree in Engineering or Life Science discipline

• 2+ years of experience in the medical device, pharmaceutical or biotechnology industry

• Clear / logical thinking with strong organization and communication skills.

• Ability to prioritize and to thrive in a cross-functional, inter-company and international environment.

• Team player and self-starter, able to perform with low supervision.

• A solution-oriented growth mindset coupled with decision-making skills.
• Experience writing work instructions, training material, and validation documentation.

Preferred: nice to have

• Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred.

• SAP (Enterprise Resource Planning quality module will be an advantage).

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit: shl-medical.com