Equipment & Software Quality Engineer

Purpose Statement: 

Support and maintain the validation system in regards to software validation.

Job Responsibilities: 

• Provide support to the validation department in regards to decisions on what systems require validation as well as support the validation/remediation of software installed in the company, maintain the change control of the software and provide guidance in IQ creation and execution.

• Identify areas that may require software validation and advice system owners about validation requirements.

• Analyze areas for improvement and recommend/advice about software solutions

• Maintain procedures related to Software Validation.

Job Requirement:  

• Minimum Degree in Computer Science/ Computer Engineering/ Electrical Engineering or related technical field. Education/ experience in software development is preferred.
• ASQ Certified Software Quality Engineering Certification (CSQE) or any professional certifications are valued.
• 3 - 5 years working experience in Software Quality Assurance within the Medical Device Industry.
• Possesses knowledge of pertinent regulations and standard regulatory requirements (e.g. ISO 13485, 21 CFR Part 820, 21 CFR Part 11, etc.) and medical device Quality Management System.
• Serves as the Quality representative for Software Control Projects, NPI as well as sustaining efforts.
• Able to support software development/validation initiatives by identifying software-related quality issues and ensuring compliance.
• Able to collaborate effectively with cross-functional team.