This is a remote position.
We are seeking a Software Quality Engineer IV to join our team.
Responsibilites:
- Supporting company goals by ensuring projects and products are delivered on time within scope and in full compliance with applicable regulatory and internal requirements.
- Providing pragmatic solutions-oriented guidance that enables teams to move quickly without sacrificing quality.
- Driving scalable quality processes that evolve with company software and machine learning platforms.
- Anticipating and mitigating compliance risks before they become roadblocks.
- Collaborating effectively across teams to build trust and alignment around quality initiatives.
Requirements
- Minimum of 5 years of experience in a software quality environment within the medical device industry.
- Proven ability to work autonomously with hands-on problem solving expertise and strong analytical skills.
- Demonstrated experience implementing IEC 62304.
- Certified software quality engineer (CSQE).
- Working knowledge of key industry standards and regulations including 21CFR 820 ISO 13485 and ISO 14971.
- Bachelor s degree in a relevant scientific engineering or related field.
- A strong intellectual curiosity with the ability to quickly grasp complex concepts contribute to shaping the quality team and thrive in a dynamic space.
- Exceptional interpersonal and relationship-building abilities with a talent for managing projects and guiding decisions across multiple internal and external stakeholders.
- Strong analytical organizational and communication skills with a demonstrated ability to adapt effectively to changing circumstances.
Benefits
- Work Location: Remote
- 5 days working
Minimum of 5 years of experience in a software quality environment within the medical device industry. Proven ability to work autonomously with hands-on problem solving expertise and strong analytical skills. Demonstrated experience implementing IEC 62304. Certified software quality engineer (CSQE). Working knowledge of key industry standards and regulations, including 21CFR 820, ISO 13485, and ISO 14971. Bachelor s degree in a relevant scientific, engineering, or related field. A strong intellectual curiosity with the ability to quickly grasp complex concepts, contribute to shaping the quality team, and thrive in a dynamic space. Exceptional interpersonal and relationship-building abilities, with a talent for managing projects and guiding decisions across multiple internal and external stakeholders. Strong analytical, organizational, and communication skills, with a demonstrated ability to adapt effectively to changing circumstances.