Quality Control Engineer 1

Quality Control Engineer

Location: Charleston, South Carolina, US

Reporting to: US Director of Quality

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 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 Quality Control Engineer will be responsible for implementing quality control processes, developing training material for QC equipment / test methods, and collaborating with cross-functional teams to resolve quality issues.

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

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 Life Science or Engineering discipline required
• 2 years of experience in the medical device, pharmaceutical or biotechnology industry
• Clear / logical thinking with strong organization and communication skills.
• 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).
• 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.
  
  

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.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your resume.

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