Director, Quality Systems & Compliance

bdx; Franklin Lakes (NJ); On-site; USD 212,000 - 339,000; Full time

Job summary

BD is seeking a senior QA leader to drive the Specimen Management Quality Systems, aligning with MDR/QMSR requirements and corporate objectives. The role requires coordinating audits, improving processes, and ensuring compliant, efficient quality practices across locations.

The ideal candidate has a BS in a technical field, 10+ years leading QA in a global matrix, and hands-on experience with Trackwise, SAP, and PEGA. Travel may be required.

Qualifications

• Bachelor of Science degree in a technical field.
• Minimum 10 years as a QA leader in a site/business unit with broad QMS responsibility.
• Expert knowledge of FDA QSR, ISO-13485, EU MDR/IVD, EU MDR/IVDR.

Responsibilities

• Lead Specimen Management Quality Systems to meet regulatory demands.
• Drive design, development, and implementation of QMS processes with corporate goals.
• Coordinate audits and inspections with regulators and internal teams.

Skills

Quality leadership

Regulatory knowledge

Audits coordination

Education

BS degree in a technical field

Tools

Trackwise

SAP

PEGA Systems

Job description

BD is seeking a senior QA leader to drive the Specimen Management Quality Systems, aligning with MDR/QMSR requirements and corporate objectives. The role requires coordinating audits, improving processes, and ensuring compliant, efficient quality practices across locations.

The ideal candidate has a BS in a technical field, 10+ years leading QA in a global matrix, and hands-on experience with Trackwise, SAP, and PEGA. Travel may be required.