Director, Quality Design for Companion Diagnostics

Scorpion Therapeutics; Carpinteria (CA); On-site; USD 137,000 - 213,000; Full time

Job summary

Scorpion Therapeutics in California is seeking a Lead Design Quality Manager for Companion Diagnostics (CDx) to oversee design assurance, risk management, and compliance activities across the portfolio.

You will lead a team, ensure adherence to design controls, support regulatory interactions, and maintain the QMS, collaborating with pharma partners to drive quality excellence and continuous improvement in a regulated environment.

Qualifications

• Bachelor's or master's degree in a relevant field.
• 2+ years of leadership experience in quality within regulated industries.
• Strong knowledge of medical device standards and IVD regulations.

Responsibilities

• Lead a team ensuring quality oversight of development processes.
• Ensure adherence to design controls and maintain the QMS.
• Support regulatory interactions and compliance activities.
• Collaborate with pharma partners and internal stakeholders.
• Provide expertise in ISO13485, FDA CFR 21 Part 820, and IVDR.
• Drive continuous improvement and risk-based quality management.

Skills

Leadership

Quality oversight

Regulatory compliance

Risk management

Cross-functional collaboration

Education

Bachelor's or Master's in a relevant field

Job description

Scorpion Therapeutics in California is seeking a Lead Design Quality Manager for Companion Diagnostics (CDx) to oversee design assurance, risk management, and compliance activities across the portfolio.

You will lead a team, ensure adherence to design controls, support regulatory interactions, and maintain the QMS, collaborating with pharma partners to drive quality excellence and continuous improvement in a regulated environment.