Design Quality Manager

October 7

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Delfi Diagnostics

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💰 $225M Series B on 2022-07

Description

• In this role, you will lead and develop DELFI’s Design Quality, Risk Management, Change Management, Process Validation, and Equipment Qualification programs from a Quality perspective. • You will provide Quality oversight and guidance to ensure compliance and effective processes are maintained, per applicable regulatory requirements and company procedures.

Requirements

• BS Required (In Science, Engineering, or equivalent). • 5+ years experience in Design Quality or directly-related field, in LDT and/or IVD or medical device industry. • Advanced working knowledge and experience in the application of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements. • Demonstrated strategic and tactical leadership building a high-performance results driven team. • Strong interpersonal and communication skills, including written and verbal communication, and presentation experience. • Previous experience in a regulated laboratory and product development environment for laboratory development test (LDT) and in-vitro diagnostics (IVD). • Ability to influence, build, and foster relationships horizontally and vertically across the organization. • Ability to address and resolve a variety of complex issues diplomatically. • Molecular diagnostics background.

Benefits

• Compensation includes bonus • Compensation includes equity • Compensation includes medical/dental/vision