Quality Engineer

Quality Engineer

Location: Charleston, South Carolina, US

Reporting to: Quality Manager

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

The Quality Engineer position would support, oversighting process transfer, launch, scale up, manufacture, and post-market of SHL product to assure SHL quality high standards and compliance with applicable requirements, regulations and SOP’s.

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

Main Responsibilities

• Team member representing Quality on product transfer activities, providing quality insight on change control, validation of equipment and processes, and during product life cycle.
• Support the development and launch of new equipment for manufacturing processes.
• Review product performance using statistics tools to identify trends focusing on customer keeping a risk based thinking to prevent quality issues.
• Support investigation of observed nonconformities during manufacturing process.
• Support Non-conformity Material Review Board.
• Stablish product inspections processes to assure sampling plans and procedures are align to customer’s needs.
• Support test methods development and transfer activities, to ensure those are reproducible by receiving unit.
• Participates in risk management activities including review failure mode effects analysis (FMEA), hazard analysis, fault tree analysis (FTA) and/or risk or statistical analysis.
• Promotes the use of statistics and a customer focus approach on product quality and control decisions.
• Review validation protocols and reports to ensure compliance to validation governance documents and GDP requirements.
• Drive Quality Improvement projects and CAPA activities to ensure prevent recurrence of observed or predicted issues and maintain a continuous improvement mentality.
• Supports creation of quality engineering procedures, systems and tools and applies them in a dynamic way to development and production projects.
• Collaborate on the review and approval of device master records.

Skills and Qualification

• Bachelor’s degree in Life Science, Mechanical Engineering or Engineering discipline
• Professional certification, such as Six Sigma, Quality Engineer are an advantage.
• 2 years of experience in the medical device, pharmaceutical or biotechnology industry.
• Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred.
• Clear / logical thinking with strong organization and communication skills.
• Risk oriented based thinking.
• 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.

Preferred: 

• SAP (Enterprise Ressource Planning quality module will be an advantage).
• ISO 11608 and 14971 experience is added advantage.
• Able to travel internationally (up to 10%).

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