Senior Quality Engineer

Becton Dickinson Sdn. Bhd.; Bayan Lepas; On-site; MYR 90,000 - 130,000; Full time

Job summary

Waters invites qualified professionals to join our team in Penang, Malaysia, to uphold regulatory standards and drive quality across the product lifecycle. The role focuses on ensuring FDA/ISO compliance, improving quality metrics, and supporting new product introductions within Advanced Diagnostic Systems.

Ideal candidates will manage Design/Device History Files, maintain risk and environmental files, and collaborate with cross-functional teams to resolve issues and standardize processes.

Qualifications

• Maintain FDA and ISO regulatory requirements across product design, manufacturability, customer complaints, assembly and test, inspection and validation.

Responsibilities

• Generate Quality information like Critical to Quality indices for project teams and operations.
• Improve key quality metrics such as First Pass Acceptance, Quality Notifications, and complaint data.
• Develop department programs and processes for continuous improvement and standardization across Advanced Diagnostic Systems.
• Support integration of new products into Manufacturing/Operations.
• Ensure divisional policies and facilities comply with regulatory policies.
• Develop Design/Device History Files per FDA requirements.
• Maintain risk and environmental files for products.

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 ofCritical 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.

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.

Required Skills

Optional Skills

Primary Work Location

MYS Penang - Bayan Lepas

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.

BD partners with organizations around the world to address some of the most challenging global health issues. Our nearly 50,000 associates across 50 countries closely collaborate with customers and partners to help enhance patient outcomes, lower healthcare delivery costs, increase operational efficiencies and expand access to healthcare.

Our state-of-the-art facilities around the globe provide an environment that enables our highly talented and passionate workforce to be the best at their professions. We are always seeking great people to join our company on its journey to greatness.

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.

BD partners with organizations around the world to address some of the most challenging global health issues. Our nearly 50,000 associates across 50 countries closely collaborate with customers and partners to help enhance patient outcomes, lower healthcare delivery costs, increase operational efficiencies and expand access to healthcare.

Our state-of-the-art facilities around the globe provide an environment that enables our highly talented and passionate workforce to be the best at their professions. We are always seeking great people to join our company on its journey to greatness.