Executive - Quality Assurance

B. Braun Melsungen AG; Chengalpattu; On-site; INR 400,000 - 600,000; Full time

Benefits offered by this job

Convenient transport and subsidized canteen services

Mediclaim and Life Insurance

Learning programs and workshops

Mental Wellness Support

Paternity & Birthday Leave

Team building events

Job summary

B. Braun Melsungen AG in Chengalpattu is searching for an Executive in Quality Assurance to uphold quality and compliance in a regulated manufacturing environment. This role requires expertise in ISO 13485 and GMP, crucial for supporting audits and driving continuous improvements.

Your commitment to high standards in safety and quality management will help shape the future of healthcare. Join our innovative team and make a difference in people's health!

Qualifications

• Strong knowledge of ISO 13485, GMP, and regulatory frameworks.
• Ability to monitor compliance activities and generate reports.
• Dedication to maintaining high standards in quality and safety.

Responsibilities

• Maintain documentation as per ISO 13485 and FDA.
• Ensure compliance with GMP standards and support audits.
• Execute validation and calibration activities for tools and processes.
• Support implementation of ISO 45001 and ISO 14001 systems.

Skills

Validation activities

Regulatory knowledge (ISO, FDA, GMP)

Analytical skills

Commitment to compliance and safety

Job description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

Executive - Quality Assurance

Company: B. BRAUN MEDICAL (INDIA)

Functional Area: Quality

Working Model: Onsite

Requisition ID: 11904

Are you an Executive QA professional passionate about ensuring compliance, safeguarding quality, and driving continuous improvement in a regulated manufacturing environment?

If so, this opportunity could be for you! Join us at our Chengalpet Plant in Tamil Nadu near Chennai, where your expertise in ISO 13485 , GMP , and regulatory frameworks will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare by ensuring the highest standards of quality management , safety , and sustainability .

Key Responsibilities

Quality & Regulatory Documentation: Maintain and manage all documentation requirements in line with QMS, ISO 13485, FDA, GMP, and Indian Medical Device Rules 2017.

Compliance & Audits: Ensure plant processes comply with ISO 13485:2016, EN ISO 13485:2016, GMP standards, and support audits/inspections.

CAPA & Continuous Improvement: Monitor CAPA processes, generate weekly reports, and drive timely closure of corrective and preventive actions.

Validation & Calibration: Execute validation activities for equipment, clean rooms, and processes; manage calibration of tools and measuring devices.

EHS & Sustainability: Support implementation of ISO 45001 Occupational Health & Safety and ISO 14001 Environmental Management Systems.

What You Will Bring to the Team

Technical Expertise: Strong knowledge of validation activities and calibration processes, both internal and external.

Regulatory Knowledge: Deep understanding of ISO, FDA, GMP, CE, and Indian Medical Device Rules 2017.

Analytical & Reporting Skills: Ability to monitor compliance activities, generate actionable reports, and ensure timelines are met.

Commitment to Compliance & Safety: Dedication to maintaining high standards in quality, safety, and environmental management.

What sets B. Braun apart?

Our state-of-the-art production facility near Chennai in Tamil Nadu was established by B. Braun Medical (India) Pvt. Ltd. Here, we manufacture over 2000 different types of Surgical Sutures, contributing significantly to the global supply of sutures by the B. Braun Group.

Our core values of Innovation, Efficiency, Sustainability, Trust, Accountability, and Diversity foster a performance-driven culture where we challenge each other constructively to grow personally and professionally. Recognized through awards such as 'Dream Companies to Work For' and 'Great Place to Work,' we invite you to join our team driven by a shared vision - to protect and improve the health of people around the world.

What can we offer you?

• Convenient transport and subsidized canteen services.
• Mediclaim and Life Insurance.
• Learning programs and workshops to drive your development.
• Mental Wellness Support with counselling and mindfulness sessions.
• Paternity & Birthday Leave for life’s special moments.
• Fun activities and team building events.

What’s next?

Upon receiving your application, our dedicated Talent Acquisition team will review your application. If you stand out, you’ll be invited to engage in dynamic interviews, ranging from phone calls to video chats and in-person meetings. Throughout this process, we will keep you informed and inspired with regular updates and feedback. Finally, if you shine through and decide to join us, we will lead you into our seamless onboarding experience. Join us and be part of something extraordinary!

We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are. To find out more about our commitment to diversity clickhere