Quality Plant Manager

Siemens Healthineers; Bengaluru; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Siemens Healthineers in Bengaluru seeks a senior quality leader responsible for QA at the radiation therapy manufacturing site, ensuring compliance with Varian QM System and ISO13485, and driving CAPA, audits, and regulatory alignment.

You will lead a local team of quality professionals, collaborate with international partners, manage risk-based topics, and support CDSCO/EUMDR readiness across manufacturing.

Qualifications

• Engineering degree in technical/scientific field; Master's degree advantageous.
• 10+ years of experience in medical device technology/manufacturing with strong quality management and leadership expertise.
• Auditor for ISO 13485, EUMDR, MDSAP; knowledge of CDSCO/AERB market access for India.
• Strong experience in non-conformance management and CAPA; planning and conducting internal and external audits.
• Proficient with MS Office; willing to learn other IT tools.
• Proven ability to collaborate with cross-functional/interdisciplinary teams.

Responsibilities

• Quality assurance for the radiation therapy manufacturing site in Bangalore to ensure compliance with the Varian quality management system.
• Act as the quality system management representative according to ISO 13485.
• Lead a local team of quality professionals with an appreciative leadership style; motivate, coach and support the team.
• Ensure and comply with the Varian QM-System requirements for the manufacturing unit of radiation therapy systems in Bangalore to sustain delivery capabilities.
• Maintain the quality management system for manufacturing per mandatory standards and regulations within the Varian QM-System.
• Prioritize, shape and optimize topics using a risk-based approach for the Bangalore site in cooperation with international partners.
• Address topics related to the effectiveness of the quality management system to the organization.
• Create, adapt and optimize processes to assure delivery of systems while incorporating ISO13485, CDSCO considerations.

Skills

English fluency

Team player

International travel up to 10%

Risk-based decision making

Ownership / independent

Fast learner

Education

Engineering degree in technical/scientific field

Master's degree advantageous

Tools

MS Office

Job description

Required Qualification

• You have a completed degree in engineering or another technical or scientific field. A master's degree is an advantage
• You have at least 10 years of professional experience related to medical device technology, manufacturing and you have in-depth experience in quality management and leadership experience
• You are a qualified auditor in standards and regulations related to medical device manufacturing such as ISO 13485, EUMDR, MDSAP and have sound knowledge and working experience with the same. You are also knowledgeable and experienced in the applicable market access process for India such as CDSCO, AERB approvals.
• You have good knowledge and experience in the area of non-conformance management and CAPA. Additionally, you have experience in planning and organizing internal as well as external audits
• You are familiar with MS Office applications and willing to familiarize yourself with other IT applications
• You have already proven your ability to successfully interact with other cross-functional / interdisciplinary teams in the past

Required Qualification

• You have a completed degree in engineering or another technical or scientific field. A master's degree is an advantage
• You have at least 10 years of professional experience related to medical device technology, manufacturing and you have in-depth experience in quality management and leadership experience
• You are a qualified auditor in standards and regulations related to medical device manufacturing such as ISO 13485, EUMDR, MDSAP and have sound knowledge and working experience with the same. You are also knowledgeable and experienced in the applicable market access process for India such as CDSCO, AERB approvals.
• You have good knowledge and experience in the area of non-conformance management and CAPA. Additionally, you have experience in planning and organizing internal as well as external audits
• You are familiar with MS Office applications and willing to familiarize yourself with other IT applications
• You have already proven your ability to successfully interact with other cross-functional / interdisciplinary teams in the past

Major Task And Responsibilities

• In your role, you are responsible for quality assurance for the radiation therapy manufacturing site in Bangalore to ensure compliance with the Varian quality management system
• You are the quality system management representative according to ISO 13485.
• You manage the local team consisting of Quality Professionals, by an appreciative leadership style. You can motivate, coach and support your team
• You are responsible for ensuring and complying with the requirements of the Varian quality management system for the manufacturing unit of the radiation therapy systems in Bangalore, to ensure the continuous ability to deliver our systems
• You are responsible for the availability and validity of a quality management system for manufacturing, based on the mandatory standards and regulations within the Varian QM-System
• You actively prioritize, shape and optimize the relevant topics using a risk-based approach for the Bangalore site in cooperation with international partners in the business area
• You can directly address topics related to the effectiveness of the quality management system to the organization
• You create, adapt and optimize processes to assure the ability to deliver systems by ensuring that all relevant aspects of quality management are considered (e.g. ISO13485, CDSCO), and you support your colleagues during introduction and establishment

Skills Required

• You are fluent in spoken and written English, allowing you to interact seamlessly within the team and with other departments
• You are a team player and enjoy working in an international, interdisciplinary team
• You are willing to undertake occasional international business trips up to 10%
• You are a sound decision maker based on a risk-based approach
• You are prepared to take ownership, and you work independently
• You are motivated by new tasks, and you can grasp new topics quickly