Quality Assurance Engineer — Impact in Medical Devices

SHL Medical; North Charleston (SC); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive compensation

Modern facilities

Challenging assignments

International team

Professional development

Job summary

SHL Medical is seeking a Quality Assurance Engineer to support molding production processes, launches, scale-up, and post-market activities, ensuring SHL quality standards and regulatory compliance across sites.

Responsibilities include change control, validation, investigations, and development of inspection and test methods while collaborating with regional and global teams to maintain consistent processes and GDP adherence.

Qualifications

• 2–5 years of experience in the medical device, pharmaceutical or related regulated industry.
• Knowledge of GMP, QSR and ISO 13485 preferred.
• Clear/logical thinking with strong organization and communication skills.
• Risk oriented thinking with ability to prioritize in cross-functional, international environments.
• Bachelor’s degree in Life Science, Mechanical Engineering or engineering discipline.

Responsibilities

• Represent Quality on product activities, contributing to change control, validation, and lifecycle reviews.
• Support development and launch of new manufacturing equipment.
• Review product performance using statistics to identify trends and prevent issues.
• Ensure Non-conforming materials are reviewed and dispositioned appropriately.
• Collaborate with Quality Control and manufacturing to confirm failures and investigations.
• Establish product inspection processes and sampling plans aligned to customer needs.
• Support test method development and transfer for reproducibility.
• Promote use of statistics and customer focus in quality decisions.
• Review validation protocols and reports for compliance with governance and GDP.
• Drive CAPA and quality improvement initiatives to prevent recurrence.
• Support creation of quality engineering procedures, systems, and tools.
• Collaborate on device master record reviews and approvals.
• Maintain technical writing for progress tracking and training materials.

Skills

GMP knowledge

QSR knowledge

ISO 13485 knowledge

Regulatory compliance

Risk-based thinking

Quality assurance

Cross-functional collaboration

Investigation skills

Documentation writing

Education

Bachelor’s degree in Life Science or Engineering

Tools

Statistical tools

CAPA management

Documentation tools

Job description

SHL Medical is seeking a Quality Assurance Engineer to support molding production processes, launches, scale-up, and post-market activities, ensuring SHL quality standards and regulatory compliance across sites.

Responsibilities include change control, validation, investigations, and development of inspection and test methods while collaborating with regional and global teams to maintain consistent processes and GDP adherence.