Job Description & Skill Requirement:

• Design and improve quality framework for Design Control to meet ISO 13485 standards with both rigor and flexibility in mind so that it works well for RUO and IVD products.

• Lead and manage design control activities for new product development, ensuring compliance with ISO 13485 standards.

• Collaborate with cross-functional teams, including R&D, Manufacturing, Quality Control, and Software, to develop and implement robust design control processes.

• Provide quality engineering support for reagent and assay development projects, including risk management, design verification, and validation activities.

• Develop and maintain design history files (DHF) and other documentation required for potential regulatory submissions and audits.

• Conduct design reviews and ensure that design outputs meet design input requirements and customer needs.

• Identify and mitigate potential quality and compliance risks throughout the product development lifecycle.

• Support the transition of products from development to manufacturing, ensuring that quality requirements are met.

• Participate in internal and external audits, providing expertise on design control and product development processes.

• Stay current with industry best practices, regulatory requirements, and emerging trends in quality engineering and life sciences.

The expected salary range for this position is between $66,500 to $1,26,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.