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Senior Engineer, Quality Assurance

3 months ago


Leesburg, Virginia, United States System One Holdings, LLC Full time

Job Title:
Senior Engineer,

Quality Assurance Location:

Leesburg, VAHours/Schedule: 8am- 5pmType: contractResponsibilities 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. RequirementsEducation / work experienceBS in a science, engineering, or related discipline.
MS, CQE, or CRE preferred.
Minimum of 3 years' experience preferred. Knowledge / competenciesPrevious industry experience desired.
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.

BenefitsSystem One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.