Quality Assurance Software Analyst

2 weeks ago


New York, New York, United States Kelly Full time

Software Quality Assurance Analyst

Location: Rochester, NY

Contract Duration: Long-term, 1+ year

Compensation: $40/hr to $55/hr (Negotiable based on qualifications)

The Software Quality Assurance Analyst is responsible for executing verification and validation processes for the Shop Floor Information Systems and other software utilized in the production and distribution of Medical Device products, specifically Contact Lenses. This role is essential in ensuring that all systems meet the necessary quality standards.

Key Responsibilities:

  • Review and approve test plans and scripts to ensure they are appropriate for validation activities.
  • Develop protocols, test scripts, and necessary documentation.
  • Oversee and participate in the execution of software-related protocols.
  • Conduct Root Cause Analysis and engage 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 the adoption of advanced systems and technologies to support the digitization of manufacturing data.
  • Adhere to local and regional Standard Operating Procedures in all tasks.
  • Engage fully in all training programs related to GMP and operational procedures, ensuring accurate completion of training records.
  • Contribute to additional projects as needed.

Position Scope:

The SQA Analyst will contribute to software or automation projects, performing verification and validation activities for computerized systems used in the manufacturing and release of Medical Devices. This role is pivotal in addressing challenges encountered in critical projects and manufacturing operations. The analyst is expected to work independently and collaboratively within the Rochester Manufacturing Operations, identifying requirements and establishing procedures to meet specific objectives.

Key Relationships:

This position requires effective communication with internal business partners across various functions, including plant quality, manufacturing, IT, engineering, logistics, supply chain, and R&D. Interaction with external auditors is also a key component of this role.

Qualifications:

A Bachelor's degree in a scientific discipline or a related field is required, with a preference for a Computer Science degree. 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 activities.
  • Familiarity with ISO 13485, FDA 21CFR parts 11, and 820 requirements, along with system development and management 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.
  • Skilled in managing a diverse workload and prioritizing tasks efficiently.


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