Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Location/Division Specific Information
Miami, Florida / Biological & Chemical Division
Discover Impactful Work:
The Engineer II, QA will play a role in is critical position calls for a strategic influencer, someone who is analytical and understands operations to impact the trajectory of our company's profitability.
A day in the Life:
The QA Engineer II will drive the execution of quality goals and objectives. Proactively driving actions to meet internal and external customer expectations for quality. Work closely with internal departments including Production, Distribution, Manufacturing Sciences and Engineering to identify causes of potential product/process failures and drive corrective and preventative actions internally and externally. Models our 4i values, integrity. Innovation, intensity, and involvement. Follows our Quality Policy by continuously improving the quality of our products & services and by ensuring global regulatory compliance.
Essential Functions

• Assist with the maintenance of ISO registration, internal and customer audit program.
• Act as change control coordinator for site specific and Media Network by reviewing the feasibility, justification, and impact of the proposed change, ensuring that referenced supporting documentation is accurate and complete.
• Provide guidance and direction as Change Control Coordinator for proposed changes.
• Review and ensure pre-implementation/post-Implementation requirements have been completed.
• Prepare and present change control metrics for Site Management Reviews.
• Act as an author for change control notifications and follow up with customers.
• Collaborate across function, using others' quality and manufacturing expertise to troubleshoot problems, interpret data, and determine next steps.
• Ensure accuracy and regular updates of documents and proper use of quality systems and processes.
• May provide guidance or direction to other personnel including assistance with prioritization and investigations.
• Responsible for the management of investigations, Corrective Actions and Effectiveness Checks.
• Supports the review and approval of Manufacturing Control Cards (MCCs).
• Supports the review and approval of Art Label content.
• May be required to perform other related duties as required and/or assigned.

Keys to Success:
Building strong teams, encouraging teamwork, fostering a positive workplace, and engaging employees.
Education

• Bachelor's degree required in a scientific field required.

Experience

• 3 years' experience in a manufacturing quality environment.
• High level of proficiency in Excel.
• Knowledge in standards and regulations such as ISO 9001 and ISO 13485.
• Strong written and oral communication skills.
• Must be able to communicate optimally with multiple levels of staff throughout the organization.

Knowledge, Skills, Abilities

• Exercises judgment within generally defined practices and policies in selecting methods and techniques for acquiring solutions.
• Acquires solutions through independent analysis but consults supervisor prior to initiation.
• Customer focused.
• Experience as a trainer/coach.
• Ability to interact with other departments and communicate at a higher level is critical.
• Excellent verbal and written communication skills, comfortable in an executive and manufacturing environment.
• Ability to handle conflict with confidence and integrity.
• Sound organizational skills and a keen ability to multi-task in a detailed-oriented environment.

Physical Requirements / Work Environment
Ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Various levels of gowning are required when entering the manufacturing area or laboratories.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!