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Quality Engineer

5 months ago

Morristown, United States KLM Careers Full time
Job DescriptionJob Description

Quality Engineer - TN

Morristown, TN

Must be a US Citizen or Green Card holder.


This position develops and executes validation protocols (IQ / OQ / PQ)

as required for equipment, sanitization/cleaning, facilities, software,

and processes. This job will also work with customers regarding

customer-specific equipment and process validations.

ESSENTIAL ACCOUNTABILITIES:

Facilitate and maintain validation project documentation, including

the Site Validation Master Plan.

Serve as the database administrator for Infinity QS (Statistical

Process Control) software.

Provide statistical analysis support for manufacturing, new product

development (NPD), trials and validation activities.

Develop SOPs relating to validation and risk management.

Monitor and prepare Key Performance Indicators (KPIs) for major customers.

Conduct quality/engineering studies to support manufacturing operations.

Facility Corrective Action / Preventive Action (CAPA) activities to

identify and resolve root cause issues through sound investigation and

effective problem-solving techniques within the manufacturing plant.

Facilitate and train associates on quality topics required for their

positions (SPC / CAPA).

Coordinate continuous improvement initiatives alongside internal and

external (customer or supplier) representatives.

Demonstrate commitment to the companys RRITE Values of Renew,

Respect, Integrity, Teamwork, and Excellence.

Associates have a direct and important role in ensuring that all work

is performed in a safe manner. Effectiveness in carrying out this

responsibility is part of each associates essential accountabilities.

Contribute to a cooperative working effort by demonstrating a

willingness to perform other job-related work, as needed or requested.

QUALIFICATION REQUIREMENTS:

(To perform this job successfully, an individual must be able to perform

each of the essential accountabilities satisfactorily. The requirements

listed below are representative of the knowledge, skill, and/or ability

required.)

Bachelors degree in engineering, science or related field is required.

Three+ years of engineering experience, preferably in a manufacturing

environment is required.

Experience in an FDA-regulated environment preferred.

Strong self-starter with the ability to work independently as well as

collaboratively in a team setting with peers and colleagues in a

cross-functional setting.

Demonstrated ability to perform technical Non-Conformance

Investigations and Root Cause Analyses.

Ability to prioritize and handle multiple tasks; ability to meet

deadlines in a fast-paced work environment.

Ability to have a flexible work schedule to support department

projects and coordinate with production and validation schedules.

Technical background in nutritional products, laboratory diagnostics,

medical devices, pharmaceutical or similar industry.

Required Knowledge, Skills, and Abilities: (Hiring Companies ATS Questions):

1. Do you have a Bachelors degree in engineering, science or related

field is required.

2. Do you have Three+ years of engineering experience, preferably in a

manufacturing environment is required.

3. Do you have experience in an FDA-regulated environment preferred.

4. Do you have demonstrated ability to perform technical Non-Conformance

Investigations and Root Cause Analyses.

5. Do you have technical background in nutritional products, laboratory

diagnostics, medical devices, pharmaceutical or similar industry.

6. Do you have Process Validation Experience

7. Must be a US Citizen or Green Card holder.