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Full-time
Posted 8h ago
~40 hrs/week
Responsibilities
The Senior Quality Engineer will maintain FDA and ISO regulatory compliance while overseeing product design for manufacturability, inspection, and validation processes. They are responsible for generating quality indices, improving key metrics, and ensuring departmental policies align with regulatory standards.
Requirements
The role requires a strong understanding of Quality Systems, FDA regulatory requirements, and ISO standards within a medical technology or regulated environment. Candidates must be capable of managing Design and Device History Files and supporting the integration of new products into manufacturing operations.
Full 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
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.1.
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.
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 (Food and Drug Administration) 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.
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
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Primary Work Location
MYS Penang - Bayan Lepas
Additional Locations
Work Shift
Related keywords
Quality EngineeringFDAISORegulatory ComplianceDesign for ManufacturabilityQuality MetricsContinuous ImprovementDevice History FilesQuality SystemsManufacturingMedical TechnologyValidationProcess ImprovementStandardizationOperationsLife Sciences
BD is the world's largest manufacturer and seller of medical equipment.
Industry
Medical Equipment Manufacturing
Company size
501-1,000 employees
Headquarters
纽约
LinkedIn followers
6,241
BD is one of the world's largest medical technology companies that produce and sell medical equipment, medical systems and reagents, dedicated to improving human health around the world.
BD focuses on improving drug treatment, improving the quality and speed of diagnosis of infectious diseases, and promoting the research and discovery of new drugs and vaccines.
BD has strong research and development capabilities to fight many of the world's most intractable diseases.
Founded in New York in 1897, the company is headquartered in Franklin Lake, New Jersey, USA and employs more than 25000 people in about 50 countries around the world.
The company's clients include medical institutions, life sciences research institutes, clinical laboratories, industrial units and the general public.
How many Healthcare jobs are open in George Town, Malaysia right now?
There are currently 38 open healthcare positions in George Town, Malaysia listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in George Town, Malaysia?
Companies currently hiring include Boston Scientific, Santen, UEM Edgenta Berhad, Allergan, Becton, Dickinson and Company, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in George Town, Malaysia?
Yes — 5 of the 38 open healthcare positions offer remote or hybrid work (0 remote, 5 hybrid).
How do I apply for Healthcare jobs in George Town, Malaysia?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.