Quality Plant Manager

Siemens Healthineers AG; Bengaluru; On-site; INR 1,500,000 - 3,500,000; Full time

Job summary

Siemens Healthineers AG in Bengaluru seeks an experienced senior quality leader to oversee radiation therapy manufacturing site quality assurance under the Varian QM framework.

The role requires ISO 13485 expertise, leadership of a local quality team, risk-based prioritization with international partners, and strong interaction with cross-functional teams to ensure compliant delivery of systems in India.

Qualifications

• Completed degree in engineering or scientific field; master's degree advantageous.
• 10+ years of experience in medical device technology and manufacturing with quality management leadership.
• Qualified auditor for ISO 13485, EUMDR, MDSAP; knowledge of CDSCO/AERB approvals for India.
• Experience in non-conformance management and CAPA; planning internal and external audits.
• Familiar with MS Office applications and willing to learn other IT applications.
• Proven ability to interact with cross-functional/interdisciplinary teams.

Responsibilities

• Quality assurance for the radiation therapy manufacturing site in Bangalore to ensure compliance with Varian QM System.
• Quality system management representative according to ISO 13485.
• Lead local team of Quality Professionals with an appreciative leadership style.
• Ensure compliance with requirements of Varian QM System for the manufacturing unit in Bangalore to deliver systems reliably.
• Prioritize and shape topics using a risk-based approach in cooperation with international partners.
• Address effectiveness of the quality management system to the organization.
• Create and optimize processes to ensure ability to deliver systems, including ISO13485 and CDSCO.

Skills

Fluent English

Team player

Willing to travel 10%

Risk-based decision making

Ownership / self-driven

Quick to grasp new topics

Education

Engineering or scientific degree

Master's degree advantage

Tools

MS Office

Job description

Job Requirements

• 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

Work Experience

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