QMS Specialist

Location: Charleston, SC

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5,000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

Job Overview

The position of the QMS Specialist participates in maintaining the Quality Management System (QMS) at the SHL Medical Charleston site. Ensures all relevant internal and external departments comply to the SHL QMS including certifications and regulatory requirements. Collaborates with regional and global counterparts to ensure consistency of processes. Effectively works with local and global employees to ensure regulatory compliance.

Main Responsibilities

• Maintaining Process Driven movement with strict adherence to safety and process procedures.
• Assist with the implementation of QMS to maintain ISO 13485 site certification for SHL in Charleston, SC with oversight of one or more of the below QMS functions:
• Processes and releases controlled documents in the SHL electronic Document Control system.
• Processes and controls storage of Quality Records including electronic and hardcopy documents.
• Reviews format and conformance necessities to documents; including but not limited to signature, dating and Good Documentation Practice.
• Assists in designing and maintaining training matrices.
• Support compilation and presentation of Management Review meeting documentation package
• Conducts internal and supports external audits as assigned to ensure compliance to company quality systems requirements.
• Additional Responsibilities may Include:
  • Support Material Review Board
  • Support Change Request & review board

Skills and Qualification

• Associate degree in Life Science or Engineering discipline with a minimum of 5 years of experience in the medical device, pharmaceutical or biotechnology industry.
• Knowledge of ISO 13485
• Knowledge of and ability to use process management tools
• Customer orientation and the ability to identify and effectively manage stakeholder expectations
• 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

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