Quality Engineer (Medical Device), Impact Business Group, Leesburg, VA
Impact Business Group -
Leesburg, VA,
US
Quality Engineer (Medical Device)
Date Posted: 2024-06-26
Job description
Job Description
Our client, a Global Medical Device Manufacture has an immediate opening for a Quality Engineer for a 6 Month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Provide quality engineering support and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulations and standards.
Position Description (Principle Duties and Responsibilities)
Qualifications
Our client, a Global Medical Device Manufacture has an immediate opening for a Quality Engineer for a 6 Month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Provide quality engineering support and direction in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance to regulations and standards.
Position Description (Principle Duties and Responsibilities)
- Advocating and leading the execution of initiatives and projects to enhance quality performance within the business and for customers.
- Ensuring compliance to regulations and standards.
- Working closely with operations and the business functions to ensure quality performance of product and processes.
- Working closely with cross-functional teams to address top quality issues.
- Reviewing of change management activities.
- Developing and providing input by identifying opportunities and weaknesses.
- Assisting in the development and review of process and equipment validation/qualification.
- Building proficiency in validation processes.
- Supporting manufacturing transfers to other plants/facilities, leading quality activities.
- Coaching and mentoring others in quality topics and activities.
Qualifications
- Bachelor's Degree in Science, Engineering, or related discipline.
- Minimum 3 years of Quality Engineering experience.
- Experience working in a compliance risk situation.
- Understanding of US and International Medical Device Regulations.
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
- Medical Device industry experience desired.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
- Familiarity with ISO 13485, GDP, GMP desired.