JOB SUMMARY:

The Principal Engineer, Quality-Software is responsible for all QMS software validation activities and identifying and leading software integration and improvement initiatives. The Software Quality Engineer will own and oversee all QMS software and supporting systems.

KNOWLEDGE, SKILLS AND ABILITIES:

• Very strong background in software structure and computer usage (including MS applications).
• Strong background in software validation and URFS development.
• Strong presentation, written, and verbal communication skills and interpersonal skills.
• Strong work ethic, ability to work in a team environment and independently on projects as needed.
• Proficient in technical report writing and review.
• Knowledge of ISO 13485, 21CFR, MDSAP, MDD, and MDR preferred.
• Project Management and problem-solving skills highly preferred.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in Computer science, engineering, or other scientific discipline. Advanced Degree preferred.
• 7+ years’ experience in the medical device industry or equivalent with an emphasis on validation, system-level software implementation, and integration project management.
• SAPByD, EtQ Reliance, and API experience preferred.
• Experience with QMS software preferred.

PHYSICAL REQUIREMENTS:

• Must be able to remain in a stationary position at least 50% of the time, including sitting at a desk and working on a computer.
• Occasionally move about inside the office and travel to and from office buildings. This may include, but is not limited to, bending and walking.
• Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
• Occasionally lift up to 15 pounds. This may be performed with reasonable accommodation.
• View and type on computer screens for long periods of time.
  This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned

• Key contributor and leader for QMS software projects.
• Create, design and upkeep of QMS software URFS documents.
• Design, write and execute QMS software validation test scripts for quality system affecting software.
• Assess and implement changes to QMS software during update reviews.
• Assists with the selection, evaluation, and implementation of QMS software solutions.
• Identifies, plans, and executes new software integration initiatives to improve the QMS.
• Identifies, plans, and executes software improvement initiatives to streamline QMS software workflows.
• Lead cross functional collaboration teams to design, write and execute software validation test scripts for Manufacturing, R&D, or other equipment which have a software component.
• Review and identify gaps in relevant published/updated standards that may affect compliance.
• Other job duties as assigned.
  Requirements: