Quality Engineer

• Location: ONSITE – Leesburg, VA

• Type: W2 contract (NO C2C OR THIRD PARTY)

• Length: until 12/2024 (Contract extension expectation)

• Pay Rate – Negotiable depending on DIRECT-related experience

• Work Authorization - Must be able to work in the U.S. with approved authorization status.

A strong candidate will also have:

• BS in a science, engineering, or related discipline.

• MS, CQE, or CRE preferred.

• Minimum of 3 years’ experience preferred.

• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired. Understanding of US and International Medical Device Regulations.

• Familiarity with ISO 13485, GDP, GMP desired.

• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics)

• Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.

• Ability to represent Quality function with project teams.

• Strong interpersonal skills, written, oral communication and negotiations skills.

• Strong in critical thinking and "outside the box" thinking.

• Highly developed problem solving skills

• Strong analytical skills

• Demonstrated ability to successfully manage and complete projects in a matrix organization

• Demonstrated ability to work independently and as part of cross-functional teams.

• Experience in working in a compliance risk situation.

• Computer literacy.

What You'll Do:

• Work closely with operations and the business functions to ensure quality performance of product and processes.

• Work closely with cross-functional teams to address top quality issues.

• Review of change management activities.

• Proficient understanding of risk management practices and concepts.

• Develop and provide input by identifying opportunities and weaknesses.

• Proficient in statistical methods and application.

• Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.

• Support manufacturing transfers to other plants/facilities, leading quality activities.

• Coach and mentor others in quality topics and activities.

Work Authorization:

• Must be able to work in the United States with current employment authorization documents.

Important information: To be immediately considered, please send an updated version of your resume to Danh704@kellyservices.com

*** (Kelly does not expense relocation/interview costs)**

In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:

• Competitive pay

• Paid holidays

• Year-end bonus program

• Recognition and incentive programs

• Access to continuing education via the Kelly Learning Center