Location: ONSITE – Leesburg, VA - Type: W 2 contract (NO C 2 C 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 ag... more details
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
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