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Quality Control Engineer

SHL Medical -
North Charleston, SC

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Job Details

Full-time

Qualifications

Laboratory testing protocol documentation
Test systems
Experience with manufacturing automation (as product category for technical sales engineers)
Laboratory equipment performance testing and validation
Quality control product testing
Procedural guides
Test equipment calibration
Engineering
Laboratory instrument validation
Technical writing experience within manufacturing
Employee relationship building
GMP
Training material drafting
Mid-level
Manufacturing facility experience
Bachelor's degree in engineering
Production validation processes
Medical device manufacturing facility experience
Task prioritization
Pharmaceutical company experience
Decision making
Laboratory compliance
Laboratory quality control
Compliance documentation
Laboratory preventive maintenance
Organizational skills
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Technical skills instruction
Training & development

Full 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

Apply Now

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