Role: DQR Technical Lead

Location: Bothell , Washington

Description:

• They are creating a transformation team who will work in improving towards product quality and reliability by looking at both the QMS and Products.
• They will intervene and define major remediations that each business needs to take on.
• Looking for SME who can direct this implementation by working closely with the R & D and cross functional team.

Expertise:

• Technical Leadership in Design, Quality, and Regulatory (DQR)
• System Engineering

Responsibilities:

• Ownership of the entire assessment process and final report generation.
• Guide and support all team members as needed throughout projects.
• Review all team members' work to ensure quality and compliance.

Hard Skills:

• Expert level in End-to-End (E2E) Product Design, including product requirements, Verification and Validation (V&V), and Risk Management.
• Proficiency in Team Management and Technical Report Writing.
• Comprehensive understanding of Compliance standards and regulations.
• Ability to conduct Systematic Overall Impact Assessments of issues.
• Familiarity/Exposure to Design Transfer/Manufacturing, Medical/Clinical processes, and Statistical/Test Sample sizing.

Soft Skills:

• Excellent communication skills, capable of explaining technical concepts to audiences with varying levels of expertise.
• Possesses a holistic view of projects and is a collaborative team player.
• Makes fact-based decisions and adapts to Agile methodologies.
• Skilled in non-judgmental conflict resolution and open-minded to alternate viewpoints.
• Effective in high-pressure stress management situations.

Experience Level:

• Experience Level: Principal
• Years of Experience in Medical Device Field: 15