TITLE: Quality Engineer
DEPARTMENT: Quality Assurance
REPORTS TO: QA Manager
Responsibilities may include but will not be limited to the following as assigned:
- Evaluate, implement, and maintain quality assurance programs and systems including Nonconforming Materials, Deviations, and Corrective and Preventive Actions to ensure product quality.
- Work collaboratively with quality and manufacturing to create and/or modify methods and procedures to ensure that appropriate processes and /or products are developed, tests are conducted and that products, materials and manufacturing equipment meet required standards.
- Perform statistical analysis to analyze trends, work with engineering and manufacturing to investigate trends, and conduct root cause analysis for nonconforming processes and products.
- Represent the quality systems in communications with vendors, customers, and auditors.
- Maintain compliance with all company policies, quality systems, and procedures.
- Perform other duties as assigned by supervisor.
- 5 – 7 years related quality experience in an ISO 13485 and cGMP in an FDA regulated environment.
- Bachelor’s degree in chemistry, biochemistry, microbiology, engineering, or a related discipline.
- Experience as a Quality Engineer in the medical device, diagnostics, pharmaceutical, or biologics field.
- Familiar with design review processes, and capable to perform risk analysis and develop risk mitigation plans.
- Previous experience with the investigation of quality events (deviations, non-conformances) and the management of CAPA systems to demonstrate effective resolution.
- Understanding of validation principles and practices, with past experience in the execution, review, and approval of validation activities.
To apply please e-mail Cover Letter and CV to email@example.com.