Quality Engineer

Company: Thermo Fisher Scientific
Location: High Point
Posted on: March 18, 2023

Job Description:

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
---------------------The Quality Engineer is a technical professional in the Quality organization that has the delegated responsibility of directly ensuring the quality work outputs and compliance of work practices for personnel from commercial production, validation, and plant engineering, and other areas as applicable. Incumbents will accomplish this by working directly with colleagues in the planning and execution of activities. The QE will employ working knowledge of manufacturing processes, regulations and quality management principles in the conduct of their responsibilities. Further, they will collect, evaluate and interpret performance indicator data to identify sub-standard performance, compliance gaps and/or performance improvement opportunities. The QE will work with colleagues to implement necessary process improvements and change.
The QE has the authority to author, participate in and or approve Standard Operating Procedures/Work Instructions, forms, test procedures, validation/qualification protocols and summary reports, internal audits, training, technical investigations, and other documents and activities requiring Quality Assurance involvement as applicable.
The QE will have the responsibility of working across functional lines to facilitate project teams in the implementation of quality or compliance improvement. They are viewed as a subject matter expert on operational quality, pharmaceutical manufacturing work process design and control, and technical problem solving. As such they are highly visible and demonstrates highly effective oral and written communication skills. Their ability to create a team approach to the management of quality and compliance is a critical success factor for the incumbent.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Applies an advanced knowledge of regulatory compliance requirements and commercial pharmaceutical operations quality principles in the operations to which they are assigned, notably softgel manufacturing, validation, engineering and associated activities. Works on complex problems in which analysis of situations or data requires in-depth evaluation of various factors. Leads cross functional teams engaged in quality/compliance improvement activities. Facilitates the increased quality/compliance knowledge of assigned area. Serves as primary resource and technical subject matter expert in areas of troubleshooting, problem solving, process/method improvement, and the assuring the quality and compliance of these activities. Directs complex technical and/or organizational problem solving activities using proven tools such as statistical analysis, screening experiments, Design of Experiments (DOE) etc. Identifies negative trends in quality/compliance and ensures correction of root causes of deficiencies. Reviews and approves Standard Operating Procedures, study design plans, manufacturing processes, qualification and/or validation protocols, investigational test plans, investigation reports, change control requests and other operational documentation where QA review and approval are required. Makes sound judgments and decisions and provides proper advice on issues of regulatory compliance and/or work product quality nature. Drives the implementation and enhancement of policies and procedures consistent with regulatory policies, customer expectations, and fundamental principles of quality. Assure the identification and implementation of advanced quality and compliance management principles and techniques resulting in positive changes in operations. Operates with minimal level of direct supervision. Assumes leadership role in managing projects, develops technical and organizational recommendations with significant impact, and uses influence to drive ongoing improvement of quality and compliance.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Additionally, an individual must uphold the standards of conduct of the company, which include confidentiality, cooperation, and respect for people and property. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education:
Bachelor's degree in Scientific/Technical discipline required.
Experience:
5+ years of related experience in the pharmaceutical industry with commercial manufacturing quality assurance experience and demonstrated working knowledge of scientific principles.
An equivalent combination of education and experience may be substituted.
CERTIFICATES, LICENSES, REGISTRATIONS
Six sigma black belt and/or CQE preferred.
SPECIAL REQUIREMENTS
Must meet applicable DEA security clearance requirements.
We offer competitive salary, an annual incentive bonus plan, and a range of other employee benefits!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Keywords: Thermo Fisher Scientific, High Point , Quality Engineer, Engineering , High Point, North Carolina