Plant QA Director: Quality Strategy and Compliance

BD; Sumter (SC); On-site; USD 100,000 - 130,000; Full time

Job summary

BD is seeking an Associate Director, Plant QA in Sumter, SC, who will lead and manage quality strategies ensuring compliance with regulations and high product safety. This role aims to minimize quality issues through effective management and strong relationships with both internal and external stakeholders.

The ideal candidate will possess a BS degree in Engineering or Life Sciences, with at least five years of managerial experience in the medical device industry. Join BD to help shape the future of healthcare.

Qualifications

• 5 years Managerial experience in a highly regulated Medical Device Plant.
• Expertise in quality compliance for medical devices.

Responsibilities

• Establish and maintain quality management processes.
• Manage quality activities including CAPA and audits.
• Supervise laboratory operations and compliance programs.

Skills

Regulatory awareness

Problem-solving

Leadership

Continuous improvement

Financial management

Education

BS degree in Engineering or Life Sciences

Master's Degree in Business or Engineering

Tools

ISO 13485

21 CFR 820

MDSAP knowledge

Six Sigma certification

ASQ certification

Job description

BD is seeking an Associate Director, Plant QA in Sumter, SC, who will lead and manage quality strategies ensuring compliance with regulations and high product safety. This role aims to minimize quality issues through effective management and strong relationships with both internal and external stakeholders.

The ideal candidate will possess a BS degree in Engineering or Life Sciences, with at least five years of managerial experience in the medical device industry. Join BD to help shape the future of healthcare.