Job Description

:X-ray is the most widely available diagnostic modality, enabling access to care nearly everywhere. We at XP, are the pioneer in X-ray imaging worldwide and our portfolio caters to an extensive range of imaging and therapy needs of our customers.X-ray group at DC will be expanding its business in Mammography, Radiography and other product lines, playing a pivotal role in shaping the future of health care diagnostics and patient care.We are seeking a passionate and dedicated individual who is committed to fostering a culture of quality excellence within our x-ray products group at DC. As a quality manager, you will play a pivotal role in ensuring the success of our products by driving a robust quality culture and ensuring compliance with quality & regulatory standards throughout all stages of product life cycle. You will oversee quality control processes and drive continuous improvement initiatives to enhance product reliability and customer satisfaction.If you are enthusiastic about championing process innovation, driving quality, and ensuring adherence to industry standards, we invite you to join our dynamic team and make a meaningful impact in the field of medical diagnostics.Responsibilities:

• Ensuring compliance with Normative, Regulative, and Statutory requirements over the entire product lifecycle. Staying up to date with healthcare regulations and standards and ensuring its timely adherence.

• Ensuring compliance with processes defined in the Quality Management system and drive process improvements in collaboration with the responsible team in XP BL

• Monitoring patient outcomes and safety: Monitoring and supporting compliance with product risk management and usability through product life cycle. Monitoring & tracking of safety complaints, incidents along with DCU and ensuring necessary CAPA implemented as necessary.

• Conducing quality assessments and Audits: Performing regular assessments, audits, and design reviews of projects to identify areas of non-compliance, inefficiency, or improvement opportunities. Escalating deviations in steering groups, executive management and requesting delivery blocks if required.

• Reporting and communication: Collecting, analyzing, monitoring, trending & tracking of quality metrics, compliance activities, improvement initiatives etc. In case of deviation, support to identify, implement, verify, validate the changes and reviewing its effectiveness. Communicate and escalate the deviations to all relevant stakeholders for timely interventions.

• Documentation: Ensuring completeness and consistency of Design history file, Device master records along with all associated documents and robust traceability between them. Establish procedures for retention, archival and easy retrieval as per the regulatory requirements.

• Collaborating with stakeholders: Working closely with Project managers and cross functional teams to promote a culture of quality and safety within the organization.

• Providing education and training: Offering training and education to the staff on quality management principles, best practices, and regulatory requirements.

• Facilitation accreditation and certification processes: Assisting DC in obtaining and maintaining accreditation and certification from relevant organizations by ensuring compliance with quality and regulatory standards.

• Technology integration: Leverage technology and digital solutions to streamline data collection, analysis and predictions if required.

Required Knowledge/Skills, Education, and Experience:

• Graduate / Post-Graduate (preferably a major in Computer Science/ Electronics/Information Technology Engineering/Business Administration/Health Economics.

• Minimum 10+ yrs. of experience in quality management of medical devices.

• Experience in Quality assurance and control, including experience with inspections, audits and CAPA processes.

• Experience in Software development, Product risk management and Usability for medical devices. Experience in non-product software validation process would be an advantage.

• Exposure to customer complaints, incident handling for medical devices.

• Knowledge of various quality, regulatory and statutory standards (e, g, ISO 9001, 13485, ISO 14971, IEC 62304 & IEC 82304 etc.)

• Knowledge of Cybersecurity (ISO 80001, SW Vulnerability Management), Information security (ISO 27001).

• Familiarity with regulations and standards of various countries.

• Excellent writing, presentation, commercial and communication skills.

• Familiar with Agile/SAFE methodologies.

• Strong leadership, collaboration skills and ability to thrive in a dynamic environment.

Siemens