Senior Software Quality Engineer (Medical Devices)

Oxford Global Resources; Gary (IN); On-site; USD 79,000 - 103,000; Full time

Job summary

Oxford Global Resources is seeking a Senior Quality Engineer focused on software quality assurance within the medical device space. You will develop and implement quality plans across the product lifecycle, emphasizing software validation, design controls, and compliance.

You will oversee risk management, perform independent assessments, and lead root cause analysis to ensure products meet customer requirements and regulatory standards.

Qualifications

• Engineering degree or equivalent experience in medical device industry.
• ASQ certified Quality Engineer.
• Working knowledge of C++, Java, Python, or other managed programming language.
• Understanding of quality philosophies, principles, systems, methods, tools, standards, and ethics.

Responsibilities

• Ensure that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design with an emphasis on software validation and design controls.
• Validate key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
• Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle with an emphasis on software
• Perform independent technical assessment on product quality performance and post-market product quality analysis
• Lead quality related problem solving and root cause analysis during design and manufacturing
• Act as a single point of contact (person assigned to project team) responsible to ensure that software based design meets quality and compliance standards for every milestone
• Function as a local subject matter expert on software validation techniques and management of electronic records and signatures
• Provide leadership and oversight to ensure Quality Management System Compliance

Skills

C++

Java

Python

ASQ Certification

Quality Assurance

Education

Engineering degree

Job description

Oxford Global Resources is seeking a Senior Quality Engineer focused on software quality assurance within the medical device space. You will develop and implement quality plans across the product lifecycle, emphasizing software validation, design controls, and compliance.

You will oversee risk management, perform independent assessments, and lead root cause analysis to ensure products meet customer requirements and regulatory standards.