Quality Compliance & Supplier Assurance Engineer

Rhythmlink International LLC; Columbia (SC); In loco; USD 85.000 - 100.000; Tempo pieno

Descrizione del lavoro

Rhythmlink International LLC in Columbia, SC seeks a Quality Compliance Engineer to maintain and improve the Quality Management System, ensuring compliance with regulatory requirements and internal procedures across supplier, product, and process controls.

The role leads supplier management, audits, CAPA lifecycle, post-market surveillance, recalls, and continuous improvement with cross-functional collaboration across Operations, Engineering, Regulatory Affairs, Manufacturing, and Supply Chain.

Competenze

• Knowledge of QMS and regulated-industry compliance requirements.
• Experience with supplier qualification, supplier monitoring, supplier auditing, supplier corrective action, or quality agreements.
• Ability to apply risk-based thinking, root cause analysis, and quality engineering principles.
• Experience with CAPA processes and regulatory reporting.

Mansioni

• Maintain and improve the QMS and records.
• Oversee supplier audits including planning, execution, and CAPA lifecycle.
• Lead or support investigations involving CAPAs and audit findings.
• Contribute to post-market surveillance plans and regulatory responses.
• Collaborate with cross-functional teams to improve compliance and product quality.

Conoscenze

Supplier management

CAPA

Regulatory compliance

Quality systems

Audits

Formazione

Degree in technical/scientific sciences

2 years' experience in regulated industry

5 years' experience in medical device manufacturing environment

8 years in a regulated industry

Descrizione del lavoro

Rhythmlink International LLC in Columbia, SC seeks a Quality Compliance Engineer to maintain and improve the Quality Management System, ensuring compliance with regulatory requirements and internal procedures across supplier, product, and process controls.

The role leads supplier management, audits, CAPA lifecycle, post-market surveillance, recalls, and continuous improvement with cross-functional collaboration across Operations, Engineering, Regulatory Affairs, Manufacturing, and Supply Chain.