QA 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

The QA Engineer is responsible for ensuring that products and processes comply with internal quality standards and external regulatory requirements. This role supports tech transfer receiving, production, and quality systems through planning, executing, and maintaining quality-related activities to ensure consistent delivery of high-quality products.

Main Responsibilities

• Act as a quality representative in cross-functional teams during production, and change control processes.
• Support implementation and maintenance of the Quality Management System (QMS) in accordance with applicable standards such as ISO 9001, ISO 13485, or IATF 16949.
• Participate in internal and external audits, non-conformance investigations (NCRs), and corrective and preventive action (CAPA) processes.
• Review and approve quality-related documentation including inspection plans, protocols, reports, and control plans.
• Support verification and validation activities (e.g., IQ/OQ/PQ) for equipment, processes, and products. · Conduct quality inspections, monitor in-process and final product quality, and provide disposition for non-conforming materials.
• Collaborate with manufacturing, engineering, and supply chain teams to resolve quality issues and drive continuous improvement.
• Maintain accurate and complete quality records and documentation in compliance with regulatory requirements.

Skills and Qualification

• Knowledge of and ability to analysis data
• Ability to prioritize and to thrive in a cross-functional, inter-company and international environment
• A solution-oriented growth mindset
• Fluent in English language, written and spoken
• Team player and self-starter, able to perform with minimal supervision
• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 2+ years of experience in Quality Assurance or Quality Engineering in a manufacturing or regulated environment.
• Knowledge of QMS standards such as ISO 9001, ISO 13485, or IATF 16949.
• Understanding of quality tools and techniques (e.g., CAPA, FMEA, root cause analysis, control plans).
• Strong attention to detail, analytical mindset, and problem-solving skills.
• Proficient in Microsoft Office and basic statistical tools.

Preferred:

• Experience with validation protocols and regulatory compliance in medical device, pharmaceutical, or automotive industries.
• Familiarity with software systems (e.g., SAP, MES, Polarion).
• Certifications such as Six Sigma (Green Belt), ASQ Certified Quality Engineer (CQE), or equivalent.

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