Job Description Summary

This position is responsible for performance of audits in support of the BD Quality Audit program.
In this role, he/she is responsible for carrying out quality audits to support the various audit programs impacting BD sites.
In addition, he/she will work with the sites to ensure submitted objective evidence is compliant with domestic and international regulations, corporate standards, and local procedures.
He/she will maintain the audit database to monitor audit program metrics and prepare reports for management.

Job Description

About BD

Be part of something bigger!

BD is one of the largest global medical device companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care.  The BD MMS Service and Support organization provides technical service and field support to BD’s dispensing customers with a mission that’s focused on knowing there’s a patient at the center of everything we do so our pledge is to deliver exceptional service to our customers.

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!

Responsibilities:

• Conducts Quality Audits to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures.
• Follows up with the auditee as required to compile information relating to the audits.
• Evaluates the adequacy of the provided evidence against the approved Audit Action Plan (AAP). In conjunction with management, develop plans to address inadequate AAP documentation when required.
• Maintains the audit system software database to record the status of all audits and associated actions. 
• Provides periodic reports to management based on the audit statuses and defined metrics.
• Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.
• This individual’s primary responsibility will be to perform quality internal audits of the various location’s Quality management systems which may result in identification of compliance risks that need to be addressed by the business to improve its compliance position and influence the quality strategy by the management team.
• This individual will also be responsible for the execution of the department’s projects and strategic initiatives.
• This individual will be interacting with individuals at various levels of the organization across multiple sites in performing audits at these assigned locations including top management.

Requirements:

• Minimum 5 years of relevant working experience in Medical Industry.

• Holding Bachelor Degree in related studies.

• Working knowledge of GDP, GMP and ISO 13485.

• Good communication skills and team player.

• Able to travel (60%)

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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

Required Skills

Optional Skills

.

Primary Work Location

MYS Kuala Lumpur - Jalan Kerinchi

Additional Locations

Work Shift