Senior Director, Quality Assurance & Regulatory Excellence

NIPRO Corporation - Global; Lewisberry (PA); On-site; USD 180,000 - 240,000; Full time

Job summary

Nipro Medical Corporation in Lewisberry, PA seeks a Senior Director of Quality Assurance to lead all quality functions at the site’s manufacturing facility. You will guide FDA inspections, regulatory audits, and quality-system transformation while partnering with cross-functional teams to drive operational excellence.

As the senior quality leader, you will manage QA, supplier quality, validation, and quality engineering, shaping a culture of compliance, accountability, and continuous improvement

Qualifications

• 15+ years of progressive quality leadership in regulated manufacturing.
• 8+ years in senior or director-level quality leadership.
• Experience in medical device, pharma, biotech, or combination products.
• Proven success with FDA inspections, audits, and remediation programs.
• ASQ Certified Quality Auditor (CQA) preferred.
• Strong knowledge of QMS, FDA regs, and global quality standards.
• Experience with ISO 13485 & MDSAP, CAPA, and root cause analysis.
• FDA 21 CFR 820 familiarity and inspection readiness.

Responsibilities

• Lead the site quality strategy aligned with corporate objectives.
• Oversee QA, Quality Systems, Compliance, Supplier Quality, Validation, and QA Engineering.
• Drive a culture of quality, compliance, and continuous improvement.
• Serve as primary site quality representative for FDA inspections and audits.
• Lead quality reviews, regulatory remediation, and 483/Warning Letter responses.
• Develop and mentor a high-performing quality organization.
• Partner with Manufacturing, Engineering, Regulatory, Supply Chain, and Leadership to mitigate risks.
• Manage budgets, resources, and performance metrics for strategic quality initiatives.

Skills

Leadership

Quality leadership

Regulatory compliance

FDA inspections

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Quality, Life Sciences, Chemistry, Microbiology, Biotechnology, Pharmacy

Job description

Nipro Medical Corporation in Lewisberry, PA seeks a Senior Director of Quality Assurance to lead all quality functions at the site’s manufacturing facility. You will guide FDA inspections, regulatory audits, and quality-system transformation while partnering with cross-functional teams to drive operational excellence.

As the senior quality leader, you will manage QA, supplier quality, validation, and quality engineering, shaping a culture of compliance, accountability, and continuous improvement