job description
Join Becton Dickinson (BD), a global leader in medical technology, as a Quality Engineer I in our dynamic manufacturing hub in Bali, Indonesia. This role is pivotal in ensuring the highest standards of product quality, compliance, and operational excellence in our state-of-the-art production facilities.
As a Quality Engineer, you will collaborate with cross-functional teams to implement robust quality control systems, drive continuous improvement initiatives, and uphold BD’s commitment to delivering life-saving medical devices and solutions. Your expertise will directly impact patient safety and regulatory compliance, making this a rewarding opportunity for professionals passionate about quality assurance in the healthcare sector.
Bali offers a unique blend of professional growth and work-life balance, with its vibrant culture and serene environment providing an inspiring backdrop for your career development.
Responsibility
- Develop, implement, and maintain quality control systems to ensure compliance with ISO 13485, FDA QSR, and other regulatory standards.
- Conduct root cause analysis (RCA) and implement corrective/preventive actions (CAPA) for non-conformances.
- Monitor and analyze production processes to identify trends, risks, and opportunities for improvement.
- Collaborate with R&D, manufacturing, and supply chain teams to ensure product quality from design to delivery.
- Perform internal audits and support external audits (e.g., customer, regulatory) to maintain certifications.
- Train and mentor staff on quality standards, procedures, and best practices.
- Prepare and review technical documentation, including SOPs, work instructions, and validation reports.
- Drive Lean Six Sigma and continuous improvement projects to enhance efficiency and reduce defects.
Qualifications
- Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical) or related field.
- Minimum 2+ years of experience in quality engineering, preferably in medical devices, pharmaceuticals, or manufacturing.
- Strong knowledge of quality management systems (QMS) such as ISO 13485, 21 CFR Part 820, or GMP.
- Experience with statistical process control (SPC), FMEA, and risk management tools.
- Certification in Six Sigma (Green Belt/Black Belt) or ASQ CQE is a plus.
- Excellent analytical, problem-solving, and communication skills.
- Proficiency in Microsoft Office, Minitab, or SAP QM.
- Ability to work in a fast-paced, regulated environment with attention to detail.