Senior Quality Engineer (Validation & Project)
Bard Sdn Bhd
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Job summary
Bard Sdn Bhd is seeking a Senior Quality Engineer (Validation & Project) to lead change control and drive site validation programs in a regulated manufacturing environment. You will develop validation protocols, manage PFMEA, and provide quality leadership across cross‑functional projects.
You will oversee IQ/OQ/PQ activities, apply statistical analysis to process capability, and ensure compliance with ISO 13485, FDA/ISO GMP standards.
Qualifications
- Bachelor's degree in Engineering, Science, Quality, or related discipline.
- 5+ years of experience in Quality Engineering, Validation, or regulated manufacturing.
- Experience in Process Validation (IQ/OQ/PQ) and lifecycle management.
- Strong PFMEA, risk management, change control systems knowledge.
- Familiarity with QMS and electronic quality systems.
Responsibilities
- Lead site change control processes and assess quality impact of changes.
- Plan, execute, and oversee validation activities (IQ/OQ/PQ, Process Validation).
- Develop and review validation protocols, reports, and PFMEA.
- Provide quality oversight for new equipment/material/Product introductions (NPI).
- Analyze process and validation data; use statistical methods for decision making.
- Lead RCA, CAPA and risk management activities.
- Monitor quality performance and drive continuous improvement.
- Support audits and regulatory inspections.
Skills
Education
Tools
Job description
Lead site change control processes and assess the quality impact of proposed changes on products, processes, and systems.
Plan, execute, and oversee validation and qualification activities including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation.
Develop, author, and review validation protocols, validation reports, qualification documentation, and Process Failure Mode and Effects Analysis (PFMEA).
Ensure all change control and validation activities are conducted in accordance with applicable regulatory requirements and BD quality standards.
Drive timely and compliant closure of change control records and validation deliverables.
Serve as the Quality Lead for new equipment introductions, new material qualifications, new product introductions (NPI), product transfers, and strategic site projects.
Provide quality oversight and technical guidance throughout project lifecycles to ensure successful implementation with full regulatory compliance.
Partner with cross-functional teams including Operations, Engineering, Supply Chain, Research and Development, and Regulatory Affairs to integrate quality requirements into project plans and timelines.
Support the development and review of quality plans, risk assessments, and quality gates for all assigned projects.
Analyze process and validation data using statistical tools and methods to evaluate process capability, stability, and compliance.
Identify process trends, variances, and opportunities for improvement through data-driven analysis.
Apply statistical techniques such as capability studies, hypothesis testing, and control charts to support validation and quality decisions.
Lead quality investigations, root cause analysis (RCA), and corrective and preventive action (CAPA) activities related to validation findings, change control, and project‑related quality issues.
Develop and implement effective risk mitigation strategies and risk management activities in alignment with ISO 14971 and applicable standards.
Monitor CAPA effectiveness and drive closure within defined timelines.
Monitor site quality performance metrics related to validation, change control, and project quality outcomes.
Identify improvement opportunities and support BD Excellence and Lean/Six Sigma continuous improvement initiatives.
Contribute to the advancement of the site Quality Management System (QMS) and quality culture.
Support internal audits, regulatory inspections, customer audits, and notified body audits related to validation, change control, and project quality activities.
Ensure ongoing compliance with quality system requirements and applicable regulatory standards.
Maintain audit‑ready documentation for all validation and change control activities.
Bachelor's Degree in Engineering, Science, Quality, or a related discipline.
Advanced degree or professional certification is an advantage.
Minimum 5 years of experience in Quality Engineering, Validation, or a regulated manufacturing environment.
Demonstrated experience in Process Validation, change control execution, CAPA management, and risk assessments.
Proven track record of leading quality integration activities for new equipment, materials, or product introductions.
Experience in cross-functional project collaboration and quality leadership in a manufacturing setting.
In‑depth knowledge of Process Validation methodologies (IQ/OQ/PQ) and validation lifecycle management.
Strong proficiency in PFMEA, risk management, and change control systems.
Competency in statistical analysis tools and process capability assessment techniques.
Familiarity with Quality Management Systems (QMS) and electronic quality systems (eQMS).
Understanding of regulatory requirements applicable to medical device or pharmaceutical manufacturing.
Experience in the medical device, pharmaceutical, or other highly regulated manufacturing industries.
Knowledge of applicable regulatory and quality standards including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and GMP requirements.
Professional certifications such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Lean Six Sigma, or PMP.
Familiarity with SAP or equivalent ERP systems used in a manufacturing environment.
Strong technical knowledge in validation, change control, and quality engineering practices.
Excellent project leadership and organizational skills with the ability to manage multiple priorities simultaneously.
Analytical and data‑driven mindset with strong problem‑solving capabilities.
Effective communicator and collaborator with the ability to influence across functions and organizational levels.
High attention to detail and commitment to regulatory compliance and quality standards.
Proactive, results‑oriented, and self‑motivated with a continuous improvement mindset.
High integrity and commitment to quality, compliance, and EHS standards.
At BD, you will have the opportunity to make a meaningful impact by driving quality excellence and innovation that supports the advancement of healthcare worldwide. You will be part of a collaborative and inclusive culture that values continuous learning, professional growth, and operational excellence.
BD is an Equal Opportunity Employer. We are committed to creating an inclusive workplace where all associates can thrive and contribute their best work.
Hirer responsiveness Salary match Number of applicants
Your application will include the following questions:
- Which of the following statements best describes your right to work in Malaysia?
Pharmaceuticals, Biotechnology & Medical Devices 1,001-5,000 employees
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.
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