Senior Quality Engineer

Responsibilities

• Review and approve quality engineering specifications for new and modified processes and designs, including product performance and test methods.
• Develop validation protocols based on business and operational needs, ensuring compliance with FDA and ISO requirements.
• Lead the execution of non-conforming material processes and provide problem-solving expertise for effective control.
• Lead CAPA (Corrective and Preventive Actions) within the area of responsibility to drive process and procedure improvements.
• Manage moderately complex risk management activities, including risk reviews, analysis, and hazard analysis maintenance.
• Ensure design change controls and production/process controls meet all local and international regulatory requirements.
• Lead the development of quality measurement and control for raw materials, processes, and finished products.
• Perform process capability studies and test method qualifications (TMV/MSA).
• Participate in internal and external audits and serve as a trainee auditor.

Requirements

• 4 to 5 years of experience in a similar quality engineering role.
• University degree in Engineering or a related field (required).
• Advanced proficiency in English.
• Strong knowledge of quality standards such as 21CFR part 820 (QSR) and ISO 13485.
• Proven experience leading CAPA processes from ownership to successful completion.
• Proficiency in Microsoft Excel and Word, with basic knowledge of SAP.
• Ability to work autonomously and provide guidance to junior engineers.
• Experience in the medical device industry is highly desirable.

About the Company

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our purpose, and we design, develop, and improve the technologies that shape how healthcare is delivered worldwide.