Engineer II, QA

Thermo Fisher Scientific - Miami, FL

Full-time - Mid Level

Miami, FL

Computer and Electronic Product Manufacturing

About the position

The Engineer II, QA position is a critical role within the Biological & Chemical Division located in Miami, Florida. This position requires a strategic influencer who is analytical and understands operations to significantly impact the company's profitability. The QA Engineer II will be responsible for driving the execution of quality goals and objectives, ensuring that both internal and external customer expectations for quality are met. This role involves close collaboration with various internal departments, including Production, Distribution, Manufacturing Sciences, and Engineering, to identify potential product and process failures and to implement corrective and preventative actions. The individual in this role will embody the company's core values of integrity, innovation, intensity, and involvement, and will adhere to the Quality Policy by continuously improving the quality of products and services while ensuring compliance with global regulations. In a typical day, the QA Engineer II will assist in maintaining ISO registration and managing the internal and customer audit program. They will act as the change control coordinator for site-specific and Media Network changes, reviewing the feasibility, justification, and impact of proposed changes, and ensuring that all supporting documentation is accurate and complete. The role also involves preparing and presenting change control metrics for Site Management Reviews, authoring change control notifications, and collaborating across functions to troubleshoot problems and interpret data. The QA Engineer II will be responsible for managing investigations, corrective actions, and effectiveness checks, as well as supporting the review and approval of Manufacturing Control Cards (MCCs) and Art Label content. The position may also require performing other related duties as assigned.

Responsibilities

• Drive the execution of quality goals and objectives.
• Proactively meet internal and external customer expectations for quality.
• Collaborate with internal departments to identify causes of potential product/process failures.
• Assist with the maintenance of ISO registration and internal audit programs.
• Act as change control coordinator for site-specific and Media Network changes.
• Review feasibility, justification, and impact of proposed changes.
• Prepare and present change control metrics for Site Management Reviews.
• Author change control notifications and follow up with customers.
• Ensure accuracy and regular updates of documents and proper use of quality systems and processes.
• Manage investigations, corrective actions, and effectiveness checks.
• Support the review and approval of Manufacturing Control Cards (MCCs) and Art Label content.

Requirements

• Bachelor's degree in a scientific field required.
• 2+ years' experience in a manufacturing quality environment.
• High level of proficiency in Excel.
• Knowledge of standards and regulations such as ISO 9001 and ISO 13485.
• Strong written and oral communication skills.

Nice-to-haves

• Experience as a trainer/coach.
• Ability to interact with other departments and communicate at a higher level.
• Sound organizational skills and ability to multi-task in a detailed-oriented environment.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare benefits
• Range of employee benefits
• Career and development prospects
• Innovative company culture that values integrity, intensity, involvement, and innovation.