Quality Assurance Engineer — Medical Devices (Global Team)

SHL Group; North Charleston (SC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive pay

Modern facility

Challenging projects

International team

Development opportunities

Job summary

SHL Medical is seeking a Quality Assurance Engineer to oversee molding production, launch, scale-up, and post-market activities to maintain SHL quality standards and regulatory compliance across global sites. You will collaborate with regional and global teams to ensure consistency of processes, support investigations and CAPA, and drive continuous improvement in a dynamic, international environment.

Qualified candidates have 2–5 years in medical device or related regulated industry, knowledge

Qualifications

• 2–5 years of experience in medical device, pharmaceutical, or related regulated industry.
• Knowledge of GMP, QSR, and ISO 13485 is preferred.
• Clear/logical thinking with strong organization and communication skills.
• Risk-oriented thinking and cross-functional collaboration.
• Ability to prioritize and work in an inter-company, international environment.
• Team player and self-starter with minimal supervision.
• Experience conducting complex investigations and implementing corrective actions.
• Bachelor’s degree in Life Science, Mechanical Engineering or engineering discipline.

Responsibilities

• Represent Quality on product 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 and focus on risk-based quality improvements.
• Ensure Non-conformity Material is reviewed and disposed accordingly.
• Partner with Quality Control and manufacturing to confirm failures and support investigations.
• Establish product inspection processes to ensure sampling plans align with customer needs.
• Support test method development and transfer activities to ensure reproducibility by receiving unit.
• Promote the use of statistics and a customer-focused approach to product quality decisions.
• Review validation protocols and reports for governance and GDP compliance.
• Drive CAPA and continuous improvement initiatives to prevent recurrence.
• Support creation of quality engineering procedures and tools for development and production projects.
• Collaborate on review and approval of device master records.
• Prepare technical documentation and training materials for progress tracking.

Skills

Regulatory compliance knowledge

Quality assurance

Statistical analysis

Investigation & CAPA

Cross-functional teamwork

Documentation

Risk management

Education

Bachelor’s degree in Life Science/Engineering

Tools

Statistical software

Job description

SHL Medical is seeking a Quality Assurance Engineer to oversee molding production, launch, scale-up, and post-market activities to maintain SHL quality standards and regulatory compliance across global sites. You will collaborate with regional and global teams to ensure consistency of processes, support investigations and CAPA, and drive continuous improvement in a dynamic, international environment.

Qualified candidates have 2–5 years in medical device or related regulated industry, knowledge