Software Quality Assurance Analyst IRC

Software Quality Assurance Analyst IRC
274465

Designation:
Test Engineer

Function:
Quality Assurance

Experience:

5-10 years

Location:

Poland

Skills:

ISO 9001:2015, Process Control, Process Quality Control, Quality Management, Requirements analysis, RISK Analyse, Risk Management, Software Testing Manual Testing, Technical Documentation, Test management

Our client is a leading digital healthcare company revolutionizing the diagnosis of cardiac arrhythmias by combining wearable biosensing technology with advanced cloud-based analytics and AI. Their mission is to become the top provider of ambulatory ECG monitoring for patients at risk of arrhythmias. To date, their continuous monitoring solutions have helped over 2 million patients and their doctors reach answers faster.

• 5+ years of experience in Quality Assurance of class II or III with embedded software in the medical device field.
• Demonstrated competency of 21 CFR 820, ISO
  13485, ISO 14971, and other international standards.
• Electro‑mechanical engineering experience and the ability to take on technical challenges through resolution is a huge plus.
• Bachelor’s Degree in an applied science or engineering field is highly desirable.
• Exceptional problem‑solving skills.
• Understands and can subsequently explain complex quality details to non‑experts.
• Exceptional organizational skills.
• Knowledge and experience with ERP/MRP systems and their applications.

We are seeking a Staff Quality Engineer to work directly with the R&D organization on new product development initiatives and wearable medical device technologies. This individual will be responsible for the ownership of the Product Lifecycle, Design Control, and Design Transfer processes, as well as, leading the quality elements of design projects as a core team member. As a Staff QE on development projects, you would lead both the hardware and firmware quality deliverables and objectives and closely collaborate with leaders and team members from R&D, Product Management, Manufacturing, Data Science, and Clinical Research organizations to ensure quality activities and processes are established in a robust manner.

Our work environment is a fast‑paced, innovative, and collaborative atmosphere. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We put the patients we serve first in everything we do. We are looking for like‑minded individuals to join our team today!

• Responsible for assuring projects meet customer expectations, quality goals, and regulatory requirements including FDA Quality System Regulations, ISO
  13485, EU MDR requirements, and Risk Management per ISO 14971.
• Apply knowledge of IEC 60601-1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle to product development and design improvement and sustaining projects.
• Serve as a Quality Engineering representative on teams engaged in new product development, quality processes improvements, business system implementations or other special projects.
• Apply knowledge in Quality Systems to execute overall project assignments and ensure robust adherence to Design Control requirements.
• Reviews and approves product documentation, drawings, process and design verification/validation.
• Serve as a technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies.
• Perform and lead risk assessment exercises in support of validation activities.
• Plans, develops, implements, and maintains the document change control system.
• Assist and participate in internal and external audits as the subject matter expert.

Culture of caring. At Global Logic, we prioritize a culture of caring. Across every region and department, at every level, we consistently put people first. From day one, you’ll experience an inclusive culture of acceptance and belonging, where you’ll have the chance to build meaningful connections with collaborative teammates, supportive managers, and compassionate leaders.

Learning and development. We are committed to your continuous learning and…