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Work Schedule

First Shift (Days)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

Location/Division Specific Information

Now is an excellent time to join our Nashville Manufacturing & Distribution team, a team committed to ensuring our customers receive the products they need to achieve their scientific goals – quickly, reliably, and safely.

How will you make an impact?

As a Senior member of the Quality Assurance Team, the Quality Engineer III will ensure compliance with industry standards and have a key role in meeting quality objectives for the Single Use Technologies business (bio-processing containers). These outstanding systems are used to develop and commercially manufacture biopharmaceutical medicines that are used to treat diseases and improve the quality of life of patients.

What will you do?

The QA Engineer III is instrumental to maintaining and improving the Quality System for the site. This individual will perform customer complaint investigation, perform assessments of Non-conforming material and deviations, lead CAPA investigation and support site quality performance metrics. Additionally, this role may support process validation activities.

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Responsibilities Include:

+ Participate & Maintain Investigative Processes (Complaints, Deviations, CAPAs)

+ Participate in internal and customer audit activities as assigned

+ Complete trending and evaluation of Complaints, Deviations, CAPAs for actions and Management Review meetings

+ Facilitate quality department process improvements projects

+ Support the validation function by assisting with validation documentation, performing qualification protocols and compiling data

+ Lead multi-functional team in CAPA and complaint investigations

+ Complete Risk and Impact Assessments

+ Directly work with customers and internal groups

How will you get here?

+ Minimum Required Education: Bachelor’s degree in Engineering or related field

+ 5 years direct Quality Engineering experience

+ Minimum 4 years of experience working with Quality Management Systems

+ 5 years of hands-on experience leading investigation processes (includes CAPA, NCM, complaint and/or root cause investigations).

+ Experience working in a regulated environment (e.g. ISO 13485:2016, 21 CFR 820, MDSAP)

Knowledge, Skills, Abilities

+ Good understanding of cGMP, GDP, and ISO 13485:2016 and 21 CFR 820) requirements

+ Innovative thinking and problem-solving skills (root cause analysis, CAPA)

+ Attention to detail and ability to identify and remediate compliance issues

+ Highly effective verbal and written skills

+ Self-motivated, proactive, and capable of adhering to timelines

+ Knowledge of Quality Management System tools

+ Understanding of plastics- materials, properties, manufacturing processes, and product assembly.

+ Excellent interpersonal, organizational, and influencing skills

+ Proficient with Microsoft tools; Word, Excel, Power Point, Visio, Teams

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 engaging company culture that stands for integrity, intensity, involvement, and innovation.

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.