Quality Control Engineer

Main Responsibilities

• Develop documentation (work instruction, training material, etc.) for the QC Lab
• Train QC Inspectors on new test methods / equipment
• Liaison and receive test method / system updates from Metrology, Testing, and transfer team
• Review planned equipment for QC lab, ensuring it meets local SHL expectations, and work in the QC Lab
• Attend Planning meetings for New Products to understand New Measuring Methods and plans for QC Testing
• Cookpoint local support (calibration / preventive maintenance) for new QC Lab equipment
• Coordinate with external SHL support teams for issues related to internal systems (SAP, EiQMI, and MES)
• Identify problem statements and build relationships 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 activities
• Perform 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

• 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)