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Quality Assurance Software Specialist

2 months ago

New York, New York, United States Kelly Full time

Software Quality Assurance Analyst

Location: Rochester, NY

This position offers a long-term contract opportunity with competitive hourly rates, commensurate with experience and skill set.

The Software Quality Assurance Analyst will be responsible for performing verification and validation tasks for the Shop Floor Information Systems and various computer systems utilized in the production and distribution of Medical Device products.

Key Responsibilities:

  • Review and approve test scripts and plans to ensure readiness for validation activities.
  • Develop protocols, test scripts, and necessary supporting documentation.
  • Oversee and engage in the execution of software-related protocols.
  • Conduct Root Cause Analysis and assist in debugging efforts.
  • Participate in the Corrective Action process to ensure effective resolution of validation issues.
  • Provide insights to enhance validation strategies, focusing on data integrity and software change control.
  • Drive initiatives towards advanced systems and technologies to support the digitization of manufacturing data.
  • Adhere to local and regional Standard Operating Procedures in all activities.
  • Engage fully in all training programs related to GMP and operational standards.
  • Contribute to additional projects as needed.

Position Scope:

The SQA Analyst will contribute to software or automation projects, executing verification and validation activities for Shop Floor Information Systems and other computerized systems. This role is critical in addressing challenges within significant projects and manufacturing operations, functioning both independently and collaboratively within the manufacturing team.

Key Relationships:

This role requires effective communication with internal business partners across various functions, including quality, manufacturing, IT, engineering, logistics, supply chain, and R&D. Interaction with external auditors is also expected.

Qualifications:

  • Bachelor's degree in a scientific discipline or a related field is required; a degree in Computer Science is preferred.
  • Alternatively, a minimum of 10 years of relevant experience in Quality, IT, or Engineering is acceptable.
  • Proven ability to execute software validation and change control processes.
  • Familiarity with ISO 13485, FDA 21CFR parts 11, and 820 requirements, particularly in the medical device sector.
  • Proficient in MS Office Suite and database software.
  • Demonstrated project management and leadership capabilities.
  • Strong written, verbal, and interpersonal communication skills.
  • Able to work effectively in a team environment and manage a diverse workload.