Validation Quality Assurance Engineer

Becton Dickinson Medical (S) Pte Ltd; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

BD is a leading global medical technology company. The Validation & Change Control team in Singapore leads site validation programs and change control activities to ensure quality systems compliance, while mentoring practitioners and guiding cross-functional teams in statistics and validation methodologies.

The role emphasizes continuous improvement and adherence to BD procedures at the Tuas Plant in Singapore.

Responsibilities

• Lead Site Validation and Change Control to ensure compliance to the quality systems.
• Lead plant validation and Change control activities.
• Ensure compliance with BD Procedures and guidelines on statistics, validation and Change Control; provide training.
• Provide training and mentorship to Validation Practitioners.
• Assess validation impact from process changes, quality investigations, CAPAs or improvement projects.
• Provide validation and statistics analysis guidance to cross-functional teams.

Job description

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

Validation & Change Control

• Lead the Site Validation and Change Control Program to ensure compliance to the quality systems.

• Lead in the plant’s validation and Change control program and activities

• Ensuring compliance with BD Procedures and its guideline on use of Statistics, validation and Change Control Provide training and mentorship to the Validation Practitioners. Assess validation impact resulting from process changes, quality investigations, CAPAs, or improvement projects. Provide validation and statistics analysis guidance and training to cross-functional teams.

CAPA & Problem Solving

• Facilitate root cause analysis and investigation using structured problem-solving methodologies and quality tools. Provide leadership and governance for the implementation of best practice, and monitoring of Corrective and Preventive Actions (CAPA) to prevent recurrence of quality issues and overdue items in the quality review board meeting.

• Drive the verification of CAPA effectiveness and sustainability through data-driven analysis, effectiveness reviews, and ongoing performance monitoring.

• Ensuring compliance with BD Procedures and its guideline on use of Statistics, root cause analysis and CAPA. Provide statistics analysis guidance and training to cross-functional teams.

Quality Activities

• Participate and or drive continuous improvement initiatives/activities. Perform risk assessment and conduct risk management activities.

• Report and review process capability activities. Perform any other tasks as assigned. Safety and ISO14001 Environmental accountability. Ensure a safe, healthy, and environmentally friendly workplace by observing Company’s rules and procedures.

• Active involvement in prevention, elimination of potential safety hazards and participation in activities which promotes recycling, replacement, and reduction of resource materials.

Safety & health accountability

• Safety and health are important to BD and we encourage the observance of all safety programs and training assigned to you.

• Such programs are to be attended in a timely manner to ensure that work tasks carried out are in accordance to our safety guidelines and SOPs.

Working Hours: 7.45am- 4.45pm

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 visithttps://bd.com/careers (opens in new window).

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

SGP Tuas - Tuas Plant