Job
Description
While technology is the heart of our business, a global and diverse culture is the heart of our success. We love our people and we take pride in catering them to a culture built on transparency, diversity, integrity, learning and growth. If working in an environment that encourages you to innovate and excel, not just in professional but personal life, interests you- you would enjoy your career with Quantiphi! Role & Responsibilities Lead the design, implementation, and continual improvement of the Quality Management System (QMS) aligned with relevant international standards (e.g., ISO 9001, ISO 13485, AS9100, IATF 16949). Ensure seamless integration of QMS into business processes across functions such as manufacturing, engineering, R&D, and operations. Develop, review, and approve quality documentation including manuals, procedures, work instructions, and records. Plan and manage changes to QMS while assessing and addressing associated risks and opportunities. Plan, conduct, and oversee internal and external audits (first, second, third-party), including certification and regulatory inspections. Manage closure of non-conformities, ensuring timely verification of corrective and preventive actions (CAPAs). Monitor QMS performance using data analysis and KPIs; identify trends and drive continuous quality improvements. Lead quality improvement initiatives using Lean, Six Sigma, Kaizen, Root Cause Analysis, and other methodologies. Provide leadership and mentorship to promote a strong culture of quality across the organization. Develop and deliver training programs on quality standards and best practices. Collaborate with cross-functional teams to embed quality principles into all operational aspects. Communicate audit findings and quality performance reports to senior management and stakeholders clearly and effectively. Stay current with industry trends, regulations, and quality standards to maintain compliance and competitive advantage. Primary Skill Experience Level: 8+ Years 5 to 10+ years of progressive experience in Quality Management or Quality Systems roles. Proven expertise in QMS implementation, maintenance, and continuous improvement. Experience managing quality audits and regulatory compliance in regulated industries such as medical devices, pharmaceuticals, or related fields. Strong knowledge of quality standards such as ISO 9001, ISO 13485, AS9100, IATF 16949. Proficiency in quality management software and tools (e.g., eQMS, CAPA, Document Control systems). Deep understanding of statistical process control, risk management frameworks (e.g., FMEA), and quality control techniques. Experience with data management and visualization tools such as Tableau, Power BI, or Qlik. Relevant certifications like ISO 9001 Lead Auditor (CQI/IRCA), ASQ CQE/CQM/CQA, Six Sigma Green/Black Belt preferred. PMP, SCRUM, or SAFe certifications are a plus. If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us ! Show more Show less
