Job Description Summary

In general, this position is responsible to focus on Quality Assurance which includes distribution quality, Post Market Quality and Customer Quality, initiating proactive measures by partnering with business and other stake holders to be business enabler Coordinating with WW team to ensure timely closures of complaints received from key customer as per business need. Ensuring timely execusion of Field Safety Notifications. Also timely notification of Adverse Event reporting to regulators.
It is the responsibility of the Quality Business Partner to proactively partner with their local Business and Functional counterparts to ensure the compliance requirements of India business are met.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Why Join Us?

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become a maker of possible with us!

Job Title: Asst Manager Quality Assurance

Department: Quality Assurance

Job Location: Gurgaon, India

Report to: Associate Director Quality India / South Asia

POSITION SUMMARY

In general, this position is responsible to focus on Quality Assurance which includes distribution quality, Post Market Quality and Customer Quality, initiating proactive measures by partnering with business and other stake holders to be business enabler Coordinating with WW team to ensure timely closures of complaints received from key customer as per business need. Ensuring timely execusion of Field Safety Notifications. Also timely notification of Adverse Event reporting to regulators.

It is the responsibility of the Quality Business Partner to proactively partner with their local Business and Functional counterparts to ensure the compliance requirements of India business are met.

KEY RESPONSIBILITIES

-Be the point of contact for department for Quality compliance management.

-Develop professional relationships with India Central and state FDA and other relevant government / non-government entities.

-Manage activities involving post market compliance to government departments like FDA, as well as other regulatory bodies as required.

-Manage all relevant Field Actions, including all negotiations with regulatory bodies and the local Business;

-Manage all relevant Adverse Event notifications, including all negotiations with regulatory bodies and the local Business within the time frames and guidelines specified

-Maintain necessary quality and compliance records.

-Maintain and develop relationships with key stake holders as well as external customers.

-In conjunction with the Sales & Marketing team provide timely information for the preparation of tender submissions and quotations for customers.

-Undertake and/or support project work as requested by India Quality Head.

-Conduct investigation and lead CAPA implementation in case of any product issue occurred during distribution chain of BD product.

-Cross train in, and perform, other quality assurance support activities as required, such as Complaints Processing.

-Support Quality Procedures and Policies as outlined in the Company’s Quality Manual. Including support for internal QA and corporate audits of the system.

-Adhere to the requirements of the Quality Management System as maintained by BD India.

-Engage Third Party Logistics (3PL) vendor leadership and provide objectives, direction and coaching to ensure alignment to DC Quality processes.

-Work with BD Supplier Management Audit organization to coordinate, schedule and conduct Supplier Audits of the 3PL’s Quality Processes at the DCs.

-Establish and enforce Quality process performance metrics for the 3PL to be used in conjunction with the Operational performance metrics established within the existing DC Quality Agreement.

POSITION REQUIREMENTS

Education:

Graduate /Master’s Degree in Science/Engineering or Quality

Relevant Experience:

1.Minimum 8-10 years relevant quality assurance/regulatory compliance experience in the medical device/healthcare industry.

2.Relevant experience in quality systems for complaint management, supply chain/warehouse, failure investigation, corrective & preventive action, and document & quality records management.

3.Manufacturing experience preferred in medical device. Experience in interaction with FDA officials will be an advantage

4.Experience in working with cross functional team

Job Competency Requirements:

-Comprehensive knowledge of Quality System standards and quality system related regulations including but not limited to ISO 13485.

-Strategic Thinker/Change Agent: High energy, accountable and forward-looking; able to see larger business picture.

-Persuasive individual with the ability to work at all levels to educate and gain buy-in for Quality programs and initiatives; track record of creating a positive imprint on an evolving business

-Effective Trusted Communicator, demonstrated ability to effectively educate and influence other stakeholders of the Quality System and compliance, encouraging ownership of quality vision and strategies.

-Problem Solver, a practical as well as analytical thinker, able to identify and diagnose problems and craft realizable solutions.

-He/she must also be able to successfully establish objectives, manage people and projects, both directly and through influence and measure results to ensure accountability.

-Must be comfortable and able to operate within a matrix organization that thrives on team work and consensus building.

-Good understanding of strategic thinking and knowledgeable in communication with regulators and Govt agencies.

-Excellent communication skills. Good knowledge of IT systems i.e. knowledge of using quality applications in ERP systems and other applications.

Living the Values

Demonstrate the behaviors that are the foundation for becoming a great Company; great performance, great contribution, great place to work:

• We do what is right
• We take personal responsibility
• We anticipate and address the challenges of patients and customers globally
• We innovate and improve continuously
• We respect, collaborate, challenge and care about each other

Leadership Competencies

Process Effectiveness – Understands results that must be obtained and establishes efficient plans for self and/or others to achieve them; alert to opportunities to improve existing processes for accomplishing work and pursues them.

• Good at figuring out the processes necessary to get things done;
• Knows how to organize people and activities;
• Understands how to separate and combine tasks into efficient work flow;
• Knows what to measure and how to measure it;
• Can see opportunities for synergy and integration where others can’t;
• Can simplify complex processes; gets more out of fewer resources.

Action Oriented – Is agile and timely in making things happen.

• Demonstrates willingness and commitment to work hard;
• Not fearful of acting with a minimum of planning;
• Seizes more opportunities than others
• Takes action when needed.

Drive for Results – Consistently strives to achieve challenging goals and objectives whether individually or through others.

• Can be counted on to exceed goals successfully;
• Is constantly and consistently a performer who adds value;
• Very bottom-line oriented;
• Steadfastly pushes self and others for results

Required Behaviors

Promotes an Inclusive Work Environment – Respects and values the diversity among us and leverages our differences to enhance our performance and working environment.

Customer Focus – Is flexible and nimble in keeping up with customer needs; is on the cutting edge of defining their next level of expectations, and working to exceed them.

Continuous and Versatile Learning – Proactively builds knowledge and skills of self and others, to increase value/contribution to the Company and to ensure personal and professional growth.

Teamwork – Puts into practice values and behaviors that contribute to group effectiveness and performance, and the achievement of team objectives.

Think Differently, Act Differently & Constructively Challenge Status Quo

• Share expertise in a positive way
• Increase collaboration, more networking & building relationships with internal & external stakeholders
• Embrace change and seek continuous improvement

Sensing & Monitoring

• Proactively participate in local industry associations
• Advocate with regulators/agencies

Travel Frequency

<25%

Click on apply if this sounds like you!

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

To learn more about BD visit: https://bd.com/careers

Primary Work Location

IND Gurgaon - Signature Towers B

Additional Locations

Work Shift