Senior Quality Engineer

BD (Tissuemed Ltd); Bayan Lepas; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading global medical technology company in Penang seeks a professional to ensure regulatory compliance and improve quality metrics for their products. Responsibilities include maintaining FDA and ISO standards, generating quality information, and integrating new products into operations. A strong emphasis on on-site collaboration is required, with a minimum of 4 days in-office presence per week. This role offers a chance to contribute to transformative health solutions.

Responsibilities

• Maintain FDA and ISO regulatory requirements in product design for manufacturability.
• Generate process/product quality information and provide recommendations.
• Improve key quality metrics such as First Pass Acceptance.
• Develop department programs for continuous improvement across BD Diagnostic Systems.
• Support integration of new products into Manufacturing/Operations.
• Ensure compliance with divisional and departmental policies.
• Develop and maintain Design/Device History Files consistent with FDA requirements.
• Understand Quality Systems and procedures.

Job description

Overview

Job Description Summary: Work with contract manufacturer in understanding BD's requirements and convert the requirement to contract manufacturing processes. Involved in new product development and sustaining activities including managing quality issues with contract manufacturer. Act as complaint investigators.

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

• Maintain FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are (but not limited to) product design for manufacturability, customer complaints, assembly and test, inspection and validation throughout the development process.
• Generate process/product quality information in the form of Critical to Quality indices and share with project team/operations recommendations and solutions to emerging issues.
• Improve key quality metrics (First Pass Acceptance, Quality Notifications and Complaint data).
• Develop department programs / processes on continuous improvement and standardization across the BD Diagnostic Systems.
• Supports the coordinated integration of new products into Manufacturing / Operations.
• Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.
• Develop Design / Device History Files and maintain in a manner consistent with FDA requirements.
• Understanding of Quality Systems and procedures.
• Other emerging responsibilities as identified and assigned.

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 Penang - Bayan Lepas

Additional Locations
Work Shift