Quality Engineer

Thermo Fisher Scientific•Indianapolis, IN

1d•Onsite

About The Position

The Quality Engineer is responsible for providing oversight for commissioning and qualification activities at the site, as well as supporting equipment maintenance. In addition, this role supports ongoing quality initiatives and projects in alignment with Thermo Fisher values. Duties also include participating in internal and external audits, conducting FMEA assessments, and driving process improvement. Candidate must be an established quality system leader, strong communicator, and able to work with minimal direct oversight. Applies Good Manufacturing Principles in all areas of responsibility. Demonstrates and drives the Thermo Fisher values- Integrity, Intensity, Involvement and Innovation (The Four l's). Responsible for ensuring GMP compliance and improving quality systems by leading or participating in projects, policy/procedure revisions. Review and approve Engineering and Maintenance documents inclusive of engineering studies, FAT/SAT, IQ, 00, and PO. Provide Quality support in the identification/development/qualification of new processes, featuring/tooling, and technologies into packaging operations. Support the development of test plans to ensure risk mitigation and quality requirements are met. Initiate and/or support in the development and/or update of Risk Management FMEA documentation in collaboration with multi-functional engineering teams per project requirements. Play an integral role in Practical Process Improvement (PPI) program. Works with FCS sites to assure consistency in validation strategy/approach for local and global projects. Conduct periodic self-inspections and participate in or internal. client and Regulatory inspections to assure cGMP requirements. Ensure that the Packaging facility and equipment are maintained in compliance with cGMPs. Conducts all activities in a safe and efficient manner. Able to partner with contacts at all levels of the organization. Additionally, periodic contact is required with the client in support of the FCS Validation Program, projects, presentations, tours, and capabilities. Strong attention to detail, collaboration, partnership, influencing, prioritization, decision-making, analytical problem solving, and verbal and written communication skills are required. Able to travel between sites, including international travel. Other duties may be assigned to meet business needs.

Requirements

Minimum Bachelor's degree in Engineering field
Minimum of 4 years total experience required with equipment/process validation experience.
Advanced experience with Microsoft Office Suite (Excel, Word, etc.) required.
Ability to work with a variety of functional areas.
Must be a self-starter, have excellent time management and organization skills, a high degree of work quality, attention to detail, and strong communication skills.
Knowledge and experience with external standards: ISO 9000/9001, ISO 13485, 21 CFR, and EU MDR especially pertaining to quality management systems, good manufacturing practices, medical devices, and auditing.
Near Vision Acuity with minimum 20/40 corrected vision (clear vision at 20 inches or fewer), color vision, and the ability to adjust focus.
Proficiency with the English language.
Ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 5-25 pounds; arm, hand and finger dexterity, including 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.
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

Experience with computer system validation is preferred.
Experience with quality system investigations, root cause analysis, and risk assessment tools preferred.

Responsibilities

Provide oversight for commissioning and qualification activities at the site.
Support equipment maintenance.
Support ongoing quality initiatives and projects.
Participate in internal and external audits.
Conduct FMEA assessments.
Drive process improvement.
Ensure GMP compliance and improve quality systems by leading or participating in projects and policy/procedure revisions.
Review and approve Engineering and Maintenance documents inclusive of engineering studies, FAT/SAT, IQ, 00, and PO.
Provide Quality support in the identification/development/qualification of new processes, featuring/tooling, and technologies into packaging operations.
Support the development of test plans to ensure risk mitigation and quality requirements are met.
Initiate and/or support in the development and/or update of Risk Management FMEA documentation in collaboration with multi-functional engineering teams per project requirements.
Play an integral role in Practical Process Improvement (PPI) program.
Work with FCS sites to assure consistency in validation strategy/approach for local and global projects.
Conduct periodic self-inspections and participate in internal, client, and Regulatory inspections to assure cGMP requirements.
Ensure that the Packaging facility and equipment are maintained in compliance with cGMPs.
Conduct all activities in a safe and efficient manner.
Partner with contacts at all levels of the organization.
Periodic contact with the client in support of the FCS Validation Program, projects, presentations, tours, and capabilities.