Quality Engineer

Responsibilities

• Identify and implement effective process control systems to support the development, qualification, and on‑going manufacturing of products to meet or exceed internal and external requirements
• Ensure quality engineering methodology systems practices meet BSC, customer and regulatory requirements.
• Create and revise departmental procedures.
• Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Develop testing and inspection methodologies and documentation for new and existing products. Generate test protocols/reports and execute qualification and validation testing.
• Review and develop validation protocols and reports. Support other functional areas during validation activities.
• Interface with other engineering departments, customers, and suppliers on quality‑related issues.
• Possess knowledge of validation techniques and associated regulatory requirements.

• Minimum degree in engineering or science.
• At least 5 years of experience in operations quality; experience in the medical device industry preferred.
• Strong problem‑solving skills using standard tools and a solid understanding of quality operations fundamentals, including product risk assessment and data analysis to identify root causes and drive solutions. Communicates findings clearly and effectively. Process validation experience essential.
• Experience in product transfer will be an added advantage.

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