Senior Quality Engineer

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

Job summary

A global medical technology company seeks a quality management professional in Penang. Responsibilities include ensuring FDA and ISO compliance, improving quality metrics, and integrating new products into manufacturing operations. The ideal candidate has experience in regulatory requirements and a proven ability to enhance product quality. Join a purpose-driven team dedicated to advancing global health through innovative solutions.

Qualifications

• Experience in regulatory compliance for medical products.
• Ability to generate critical quality indices and share recommendations.
• Proven track record of improving key quality metrics.

Responsibilities

• Maintain FDA and ISO regulatory requirements.
• Generate process/product quality information.
• Improve key quality metrics like First Pass Acceptance.
• Develop continuous improvement programs.
• Support integration of new products into manufacturing.
• Ensure compliance with divisional policies.

Skills

Understanding of FDA and ISO regulatory requirements

Experience in product design for manufacturability

Ability to handle customer complaints

Process improvement knowledge

Understanding of Quality Systems

Job description

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!

Job Description

• 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.

Eligibility and Location

Primary Work Location: MYS Penang - Bayan Lepas.

Additional Locations: (none listed).

Work Shift: (not specified).

Equal Opportunity

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.