Quality Assurance Software Specialist

1 week ago

New York, New York, United States Kelly Full time

Software Quality Assurance Analyst

Location: Rochester, NY

This position is a long-term contract opportunity, offering competitive compensation based on 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.

This role focuses on the manufacturing platform for Contact Lenses and requires strong communication skills to guide teams in making informed Quality decisions. The SQA Analyst must demonstrate self-motivation and initiative in identifying and addressing areas for improvement while promoting Quality initiatives.

Key Responsibilities:

  • Review and approve test scripts and plans to ensure they are suitable for validation activities.
  • Develop protocols, test scripts, and relevant documentation as necessary.
  • Oversee and participate in the execution of software-related protocols.
  • Conduct Root Cause Analysis and engage in debugging processes.
  • Participate in the Corrective Action process related to validations to ensure effective follow-up and resolution.
  • Provide insights to enhance validation strategies, focusing on data integrity, verification, and software change control.
  • Drive advancements towards modern systems and technologies that support the digitization of manufacturing data.
  • Adhere to local and regional Standard Operating Procedures while executing responsibilities.
  • Engage fully in all GMP and operational training programs, maintaining accurate training records.
  • Contribute to additional projects as needed.

Position Scope:

The SQA Analyst will serve as a key contributor on software or automation projects, conducting verification and validation activities for Shop Floor Information Systems and other computerized systems used in the manufacturing and release of Medical Devices. This role is crucial in addressing challenges within critical projects and manufacturing operations. The SQA Analyst will work independently and collaboratively within the manufacturing operations team, demonstrating the ability to identify requirements and establish procedures and objectives. Coordination of work activities and providing guidance to peers will be essential.

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 expected.

Qualifications and Training:

A Bachelor's degree in a science-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.

The ideal candidate will have:

  • Proven experience in executing software validation and change control activities.
  • Knowledge of ISO 13485, FDA 21CFR parts 11, and 820 requirements, along with system development and management in the medical device industry.
  • Proficiency in MS Office Suite and database software.
  • Demonstrated project management and leadership capabilities.
  • Strong written, verbal, and interpersonal communication skills.
  • The ability to thrive in a team environment.
  • Effective workload management and prioritization skills.

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