Senior Quality Engineer

BD; Bayan Lepas; On-site; MYR 90,000 - 120,000; Full time

Job summary

BD is seeking a Quality/Regulatory Affairs professional to join our Advanced Diagnostic Systems team in Penang, Bayan Lepas. You will maintain FDA and ISO regulatory requirements, drive design for manufacturability, and manage quality data across development and manufacturing processes.

You will lead continuous improvement programs, support new product introductions, ensure compliance with policies, and maintain Design/Device History Files in line with FDA expectations.

Responsibilities

• Maintain FDA (Food & Drug Administration) and ISO (International Organization for Standardization) regulatory requirements. Key elements of focus are 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 Advanced Diagnostic Systems.
• Supports the coordinated integration of new products into Manufacturing / Operations.
• Ensures Advanced 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, including maintaining of risk files and environmental files for the products.
• Supplier auditing and monitoring as issues arise (including SCAR management) and drive to resolution
• Managing deviations and change management/change control for the products
• Other emerging responsibilities as identified and assigned.

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

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.

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 (Fist Pass Acceptance, Quality Notifications and Complaint data).
• Develop department programs / processes on continuous improvement and standardization across the Advanced Diagnostic Systems.
• Supports the coordinated integration of new products into Manufacturing / Operations.
• Ensures Advanced 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 (Food and Drug Administration) requirements
• Understanding of Quality Systems and procedures, including maintaining of risk files and environmental files for the products.
• Supplier auditing and monitoring as issues arise (including SCAR management) and drive to resolution
• Managing deviations and change management/change control for the products
• Other emerging responsibilities as identified and assigned.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Primary Work Location

MYS Penang - Bayan Lepas