Engineer II, QA

at  Thermo Fisher Scientific

EDUCATION

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

EXPERIENCE

• 2+ 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.

• 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.