Software Quality Assurance Engineer

Responsibilities:

• Work with Engineers and leadership in the IT/IS, Manufacturing, R&D and QA departments to control software changes.


• Serve as a key team member in harmonizing and maintaining coordination of software validation program.


• Create Quality System documentation and provide training on AGA’s software validation program.


• Provide best-practice guidance for compliant change control in respect to 21 CFR 820, 11, ISO 13485 and SOX 404.


• Create software validation deliverables or serve as the validation lead if required.


• Peer review software validation deliverables as required.


• Review and approve software validation deliverables, including final approval of systems for GxP use, when designated as the Quality reviewer by the Quality System Program Manager.


• Lead the coordination of Calibration and Preventative Maintenance programs.


Qualifications:

• Bachelor's degree in related field.


• 5 or more years of related professional experience required


• Software validation experience


• Training in and exposure to Calibration and Preventive Maintenance processes and tools


• Experience in medical device industry preferred


• Training in and exposure to validation processes, best practices and compliance considerations in the medical device industry.


• Extensive Information Systems/Technology knowledge, including hardware, software, databases, operating systems. Programming knowledge is not required but is preferred.


• In-depth understanding of ERP systems, data warehouse technology, automated manufacturing, environmental control, automated testing equipment, adverse events/medical reporting and clinical data systems.


• Excellent organizational, interpersonal, and communication (verbal/written) skills.
  
• Detailed-oriented.


• Ability to constructively interact with a range of personalities and positions, both inside and outside the organization.


• Ability to work creatively and productively with minimal supervision.


• Ability to coordinate and ensure completion of program deliverables within predetermined timelines.

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We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more.

An Equal Opportunity / Affirmative Action Employer

Please, No Agencies.