Clinical and Digital Devices Quality Lead – Pharmaceuticals [F/M/X]
Do not wait to apply after reading this description a high application volume is expected for this opportunity.
Permanent Job
Mission Overview
Shape the quality framework for cutting-edge clinical digital devices in a fast-paced medical technology environment. This role bridges biomedical engineering expertise with pragmatic quality assurance, ensuring innovative digital health solutions meet the highest standards while maintaining speed to market.
Your Impact
Establish and lead quality processes for digital clinical devices from concept through deployment, balancing regulatory rigor with innovation velocity in an evolving startup-like environment.
Core Responsibilities
Digital QA Leadership:
Design and implement quality frameworks specifically for digital health devices and software.
Risk-Based Approach:
Prioritize quality activities based on actual patient safety and regulatory impact.
Technical Translation:
Convert complex technical requirements into clear, actionable guidance for cross‑functional teams.
End‑to‑End Quality:
Oversee device lifecycle quality from development through clinical deployment.
Cross‑Functional Leadership:
Guide small, agile teams through quality decision‑making processes.
Stakeholder Communication:
Present technical quality concepts to non‑technical audiences including clinical and business teams.
Solution Architecture:
Identify quality risks and propose practical, innovative solutions.
Your Profile
Professional Foundation
Educational Background:
Degree in biomedical engineering, engineering, life sciences, or software‑related fields.
Experience Level:
3‑5 years in quality assurance within medical technology or digital health.
Digital Mindset:
Strong understanding of software development and digital device technologies.
Fluent in English.
Core Competencies
Pragmatic Approach:
Focus on what truly matters rather than perfectionism.
Structured Thinking:
Organize complex information into clear, prioritized action plans.
Synthesis Skills:
Distill technical complexity into concise, understandable insights.
Ownership Mentality:
Take full responsibility for quality outcomes within a lean team structure.
Work Style
Adaptability:
Thrive in fast‑changing, imperfect environments.
Leadership:
Comfortable leading quality initiatives without extensive hierarchy.
Communication:
Exceptional ability to explain technical concepts to diverse audiences.
Full remote possible.
Environment & Culture
Innovation Focus:
Work with cutting‑edge digital health technologies.
Agile Structure:
Small, evolving teams with minimal bureaucracy.
Impact Opportunity:
Shape quality processes from the ground up.
Growth Potential:
Expand expertise across clinical, digital, and regulatory domains.
Equal Opportunity Statement
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. xphnsxz For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
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