NubGenix mainly focuses to support start up and mid-size medical device, combination products and pharmaceutical organizations. We provide support from early development through post-market phases. We also assist in designing, establishing and execution of complete Quality Management System (QMS).

Experienced Quality Leader who led the overall compliance of Takeda Global Quality Device and Combination Products (DCP) processes and quality records against changing device and IVD regulations. I was responsible for establishing certification and product licensing, oversight of regulatory labeling for DCP products, and act as the designee of Head of Device Quality Compliance and Product Surveillance as required.– Spearheaded strategic planning of Brexit transition by performing gap assessment and implement the quality compliance plan. – Implemented key business solutions to ensure a successful transition from EU MDD to EU MDR such as CE marking, essential requirements, vigilance, and economic operators. – Facilitate and led successful internal and external audits to ensure compliance with global regulations including FDA, ISO, MDSAP, and EU MDR. – Led cross-functional strategic projects supporting commercial and clinical complaint management system.– Implemented and deployed global product compliance process for FDA’s single reporting regulatory requirements for devices and combination products by engaging/partnering with key stakeholders and cross-functional teams. – Tracked global Device and Combination Products licenses/certifications/registrations to ensure appropriate Takeda commitments are implemented and in compliance. – Influenced stakeholders and colleagues in a highly matrixed and diverse global business environment.

Established and drove global product quality assurance and operational efficiency by leading compliance activities for devices/combination products including but not limited to batch disposition, internal/external audits, supplier management, management review, and complaints management

Active participant of the Management Team to develop strategies for QA initiatives in support of divisional business initiatives. Formulate and implement an annual Quality Plan, departmental goals, action plans, and budgets according to Corporate and Departmental priorities.

Managed staffing, training, mentoring, and guided four (4) Quality Engineers and five (5) Customer Complaint Technicians to maintain and improve product quality and systems consistent with department and strategic objectives.

Represented as a “Quality Lead” to identify and implement the new requirements of quality standards of ISO 14971 – Quality Risk Management of Medical Devices, Collaborated with cross-functional teams and supported qualification and delivery of new products worth $1.0M.

Managed, coached, and supervised daily activities of six (6) quality control inspectors and assigned resources to meet the organization's objectives.

Managed and supervised a team of 3 quality control (QC) inspectors to ensure that the organizational requirements are met.