Quality System Specialist II

Becton Dickinson Medical Devices•Sumter, SC

2d•Onsite

About The Position

The Quality System Specialist II manages the plant’s corrective/preventive action system, internal audit system, customer complaints, and other assigned activities related to FDA and ISO compliance. The role supports identification and resolution of quality assurance and regulatory issues related to product lines, helping ensure compliance with FDA regulations, ISO standards, corporate directives, and company strategies. The position reports directly to the Quality Manager, Quality Systems. Responsibilities include evaluating and investigating customer complaints; coordinating documentation review, sample testing, and root cause analysis; analyzing complaint data and trends; maintaining complaint and investigation records; and auditing corrective actions for effectiveness. The role may participate in internal and external audits, conduct quality training, manage CAPA and internal audit programs, plan and perform plant systems audits, coordinate audit teams, and conduct supplier audits as directed. Returned samples must be handled safely, with precautions for potentially contaminated or sharp products.

Requirements

High school diploma or GED.

Nice To Haves

2–3 years of related work experience preferred.

Responsibilities

Evaluate customer complaints, coordinating documentation review, sample testing, and root cause analysis.
Lead or facilitate complaint investigations to reduce or eliminate the causes of complaints.
Analyze complaint data, report trends and triggers for significant issues, identify significant changes, and identify chronic complaint categories.
Document complaint analysis, failure investigations, corrective and preventive actions, and effectiveness; maintain related files according to policy and procedures.
Handle returned samples safely, taking necessary precautions for contaminated and sharp products.
Audit corrective actions implemented to remedy complaints for effectiveness.
Participate in internal and external audits as needed, develop audit reports, and communicate results to auditees and the quality group.
Conduct quality training as required to support compliance with federal regulations and international standards.
Manage the plant’s corrective/preventive action system as assigned and perform Site CAPA Leader responsibilities defined in established procedures.
Manage the plant internal audit program as assigned to ensure compliance with applicable federal regulations and international standards.
Plan and perform intensive audits of plant systems and procedures, and coordinate audit team training, scheduling, performance, and reporting as necessary.
Conduct supplier audits to ensure compliance with QSR/ISO as directed by material requirements and company guidelines.