Quality Assurance Engineer

1 week ago

Lebanon, United States Kymanox Full time
Description

Is Kymanox the right fit for you?

You want to make a difference and have an impact...

You enjoy having an influence in your day-to-day work...

You are motivated by working alongside a team filled with

subject matter experts who will help you learn and grow...

You wake up every day and do what you do

because patients deserve better.

If this sounds like you, you've come to the right place.

The Quality Assurance Engineer will join our Manufacturing and Automation team and provide support to various clients covering a wide range of technical and compliance challenges. In addition to support from a direct, functional manager, work will also be done under the guidance of a senior Kymanox engineer and/or senior project manager.

Responsibilities:
  • Process development, scale-up, qualification, and/or technology transfer.
  • Design, specification, selection, implementation, and/or startup of manufacturing/development facilities, utilities, equipment, and systems.
  • Troubleshooting, root cause problem solving, and continuous improvement of processes, equipment, and systems.
  • Request for proposal creation, project estimating, capital requests, vendor selection & management, and project budgeting.
  • Direct experience with, and application of, project management concepts and tools.
  • Knowledge of statistical analysis and related tools and programs a plus.
  • Possesses the ability to drive program and project initiatives from the concept phase to full implementation.
  • Possesses a strong business acumen and ability to engage, build, and maintain strong client relationships.
  • Commissioning/Qualification/Validation of facilities, utilities, equipment, and systems.
Educational Background:
  • The ideal candidate will have a bachelor's degree in a science-related field such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering.
Experience:
  • 2+ years of experience in the US medical device, pharmaceutical, or combination products industry.
  • Experience with generating SOPs for site readiness or technical operations is preferred
  • Knowledge of Technical Writing and CGMPs and drug/device development.
  • Experience with MS Office products (Outlook, Excel, PowerPoint, Word) strongly preferred.
Desired Aptitude and Skill Set:
  • Detail-oriented
  • Strong organizational skills and verbal/written communication skills
  • Highly motivated self-starter with a sense of ownership and willingness to learn
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Ability to form partnerships with internal stakeholders
  • Seasoned soft skills (i.e., high EQ)
  • Technology savvy


Travel:

Up to 10% travel is possible for support at tradeshows, conferences, and related events. A passport is required for this job.

Career Development:

The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization.

Compensation:

Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process - as well as market conditions. Eligible for incentive program after 90 days of outstanding work.

Benefits:

Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.

Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.

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