- 15+ years of experience in Quality Assurance experience in Medical Devices, Pharmaceuticals, or other regulated manufacturing industries, including 5+ years in a leadership role.
- Strong expertise in ISO 13485, GMP, EU MDR 2017/745, ISO 14971, CAPA, Validation, Risk Management, Supplier Quality, and Regulatory Compliance.
- Proven leadership in managing cross-functional and multi-site quality teams, driving quality culture, regulatory audits, process improvements, and organizational transformation.
- Develop plant layout and material flow optimization.
- Drive continuous improvement and low-cost automation initiatives.
Preferred Candidate Profile:
- Bachelor’s degree in Engineering, Pharmacy, Life Sciences, Biotechnology, or a related field, with ISO 13485 Lead Auditor certification (Six Sigma/ASQ CQE certifications are an added advantage).
- Strong customer-facing experience with regulatory authorities and key stakeholders during inspections and audits.
- Good knowledge of Plant Layout, VSM & Continuous Improvement.
Contact for more details
Ms Anitha
9047577166
anitha.m@haarvard.com
