Job Title: Senior Engineer, Quality Assurance

Location: Leesburg, VA

Hours/Schedule: 8am- 5pm

Type: contract

Responsibilities

• 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.

Requirements

Education / work experience

• BS in a science, engineering, or related discipline.
• MS, CQE, or CRE preferred.
• Minimum of 3 years' experience preferred.

Knowledge / competencies

• Previous 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.

Benefits

System 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.