Head of Quality and Regulatory Compliance Getinge

15.0 - 19.0 years

0 Lacs

karnataka

On-site

As the Head of Quality and Regulatory Compliance at the India Innovation Center (IIC) in Bangalore, India, you will play a crucial role in leading the Quality and Compliance Groups within the organization. Reporting to the Supervisor Director Quality and Compliance Critical Care, you will be an integral part of the leadership team at Getinge India. Your primary responsibility will be to ensure the effective establishment and maintenance of quality systems in the projects executed at IIC. You will be tasked with providing strategic leadership and management for the Quality Systems at the IIC, developing a competent and accountable Quality organization aligned with business objectives and compliance standards. Your role includes building a quality management system and fostering a quality culture at IIC, ensuring effective implementation and maintenance of the quality management system, and reporting on its performance to top management. Additionally, you will have the authority to act on behalf of top management during internal and external audits, manage quality audit functions, contribute to corrective and preventive action activities, and oversee the implementation of ISO13485 and MDSAP along with QSR. Stakeholder management and leading change will be of high importance in this role. Furthermore, you will serve as the divisional Management Representative, overseeing third-party quality systems inspections and audits, preparing audit responses, and working with cross-functional teams to ensure quality metrics align with corporate goals. Your ability to establish credibility, drive continuous improvement, manage departmental costs, and instill personal accountability for quality will be critical to the success of the organization. To qualify for this position, you must hold a Bachelor's degree in engineering or a Life Science related field, along with a minimum of 15 years of hands-on experience in Quality Assurance, preferably in the medical device industry. You should be capable of working from the ground up to build a quality system that exceeds global requirements and customer expectations, demonstrating a startup mindset and progressive leadership experience. Strong knowledge of FDA and EU regulatory compliance, Quality System Regulation, Quality System Inspection Technique Audits, as well as excellent communication, leadership, and interpersonal skills are essential for this role. You should also be proficient in MS Office applications and possess the ability to coach, develop, and motivate associates within the Quality Organization. If you are a dynamic leader with a proven track record in quality and regulatory compliance, capable of driving organizational excellence and continuous improvement, this role offers a unique opportunity to make a significant impact in a challenging and rewarding environment.,

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Sales Officer Sofomation Energy Consultants

8.0 - 13.0 years

15 - 27 Lacs

Ahmedabad

Work from Office

Role & responsibilities Degree in Marketing, Sciences, Biomedical Engineering, or related discipline. Medical Device Certification Business experience preferred. About 8 years of experience with a Medical Devices manufacturer and / or Notified Body including about 2 years in Sales desirable. Good Communicator & writing skills. Social Media selling exposure. Well-read and updated on the Medical Device Sector happenings. Experience with ISO 13485, MDSAP, MDD, MDR, IVDR certifications. Establish rapport and liaison with Regulatory bodies and seek advance information on legal/regulatory introduction/amendments. Connects and actively interacts with Medical Device Industry forums. Generates proposals in compliance with Notified /Accreditation Body requirements and/or product sector requirements. Maintains accurate records of all sales and prospecting activities including sales calls, presentations, closed sales, and follow-up. Adheres to internal standards, policies and procedures.

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Risk Management SME Mount Talent Consulting

10.0 - 14.0 years

13 - 20 Lacs

Pune

Work from Office

Job Description: Degree in mechanical engineering, electrical engineering, applied sciences or a related discipline; 10+ years of professional experience in medical device in Risk management , regulatory Quality systems EU MDR, US FDA and closely working R&D, Regulatory Affairs & design quality organizations Strong proven experience in simplifying/reviewing RMM,BRD, RMF, Trace matrix, DHFs, Design requirements, IFUs, Risk management , V&V activities etc. Expertise in interpreting & implementing various medical device standards and guidance's, such as IEC , ISO. Experience with systems for quality management, product development, and follow-up of procedures Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.) Ensures that appropriate Quality Plans are made that include all stages product life cycle ,supports Quality Plan Validate key design inputs like : Usability, Reliability, Performance, Supportability, Manufacturability, Safety, Security, Privacy, Serviceability, Sustainability etc. Provides effective oversight of the execution of the Quality Plan, Risk Management activities, and all design related activities during the product/system life cycle Performs independent technical assessment on product quality performance and post-market product quality analysis Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required Act as a single point of contact (person assigned to project team) responsible t ensure that hardware design meets quality and compliance standards for every milestone etc.)

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