Quality Control Engineer

SHL Medical; North Charleston (SC); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Competitive compensation package

Modern working environment

Challenging assignments

Personal and professional development opportunities

Job summary

A leading medical device company is seeking a Quality Control Engineer to join their team in South Carolina. In this role, you will develop documentation and train inspectors while ensuring compliance with quality standards. The ideal candidate has a Bachelor's degree and at least two years of experience in the industry, along with strong communication skills and the ability to thrive in a dynamic environment. This position offers competitive compensation and opportunities for professional growth.

Qualifications

• 2+ years of experience in the medical device, pharmaceutical or biotechnology industry.
• Experience writing work instructions, training material, and validation documentation.
• Knowledge of regulatory compliance: GMP, QSR, and ISO 13485.

Responsibilities

• Develop documentation for the QC Lab.
• Train QC Inspectors on new test methods.
• Serve as liaison for test method updates.
• Coordinate calibration for new QC Lab equipment.
• Act as point of contact for QC Lab changes.
• Manage QC equipment for testing and validation.

Skills

Clear / logical thinking

Strong organization skills

Communication skills

Ability to thrive in a cross-functional environment

Team player

Self-starter

Solution-oriented growth mindset

Decision-making skills

Education

Bachelor’s degree in Engineering or Life Science

Tools

SAP

Job description

Join to apply for the Quality Control Engineer role at SHL Medical.

Location: Charleston, South Carolina, US

SHL Medical is a world‑leading provider in the design, development, and manufacturing of advanced self‑injection devices. With 6,000 employees worldwide, 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, we also operate key sites in Sweden, Taiwan, and the US. We are committed to innovation, impact, and growth, and we empower our people to develop solutions that make a meaningful difference in patients’ lives while fostering a supportive, inclusive, and dynamic workplace.

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
• Serve as liaison and receive test method / system updates from Metrology, Testing, and transfer team
• Review planned equipment for QC lab, ensure it 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
• Act as point of contact for QC Lab for any upcoming changes or needs
• 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 Qualifications

• 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 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
• 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 pre‑employment 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

Seniority Level

Associate

Employment Type

Full‑time

Job Function

Quality Assurance

Industries

Medical Device