Medical Device Quality Engineer

*the position in NOT for SW QA!!!*

Vectorious is revolutionizing heart failure treatment with the world’s first in-heart microcomputer. Driven by our vision to accelerate care for chronic heart failure patients, we’ve developed a groundbreaking sensing platform that delivers accurate and actionable clinical insights. As part of the FDA’s prestigious Breakthrough Device Designation program, we are making a tangible impact on millions of lives. 🌐

We’re a young, dynamic team looking for a talented Quality Engineer to join us on this exciting journey. If you're passionate about making a difference and have the skills to contribute, apply today for an exciting opportunity! 💙

Responsibilities:

• Provide Quality Engineering support to various teams in product realization cycle.
• Provide quality and compliance guidance for process owners responsible for design, development and production of medical devices
• Assist with defining and documenting deliverables in DHF / DHR files in accordance with internal procedures / work instructions and in compliance with applicable quality and regulatory requirements
• Take active role in risk management activities (DFMEA/PFMEA).
• Handling non-conformities detected in production and participate in MRB committee
• Review DMR and manufacturing documents, work instructions and procedures, engineering/design change reports (ECOs) and provide inputs related to QA/QC.
• Approve and sign design/manufacturing documents and deliverables as Quality Representative and ensure their compliance with QMS procedures

Qualification:

• Bachelor’s degree in engineering/Scientific field
• 3+ years of experience in Quality Assurance at Medical Device companies (active implants companies – an advantage)
• Familiarity with international quality regulations –ISO 13485, ISO 14971, US 21 CFR 820 etc.
• Experience in writing and reviewing manufacturing procedures/ work instructions/ forms related to manufacturing processes.
• Experience in implementing and guide quality standards in day-to-day activity
• Ability to collaborate with various departments within the organization
• Experience in product and process validation, test method validation, statistics, risk management tools
• Experience handling non-conformities (NCR/MRB) in production.
• Languages: English – excellent level

Why join Vectorious?

• Life first: We prioritize improving lives—for our patients and our team members.
• Culture of curiosity: We encourage critical thinking, adaptability, and creativity to drive innovation.
• Passion and professionalism: Our team is united by a shared commitment to excellence and collaboration.
• Growth mindset: We value individuals who are hungry for change, success, and personal development.
• Top-tier team: Work alongside talented, motivated professionals who push boundaries and disrupt the status quo.