About the job

BG Medical has been a leading medical device distributor of surgical mesh for almost 20 years in the United States and is now manufacturing this life-changing product. We are looking for a Quality Assurance Engineer to join our expanding team on a full-time, or potentially part-time, basis. Candidates should have experience in a similar manufacturing environment (clean room), preferably in medical device. Our organization is experiencing rapid growth and boasts an innovative product line that's making a significant impact in the medical device industry and in the lives of patients every day all across the country.

Description

The Quality Assurance Engineer will be responsible for:

• Supports regulatory and agency inspections, audits, investigations, and inquiries related to product design and manufacturing quality control and assessment.
• Leads and implements various methodologies for product and process improvement.
• Working with sterilization of products, including re-validation and microbiological testing, including product release
• Reviews the adequacy and accuracy of changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, and more.
• Oversees the completion and maintenance of risk analyses.
• Manages the generation and completion of protocols and reports for test method validations.
• Collaborates with Manufacturing Engineers to review processes for new and existing products, coordinating process validations and capability studies, and recommending monitoring devices when appropriate.
• Develops inspection techniques and procedures to ensure product integrity in line with design specifications, responsible for writing, approving, and implementing Incoming, In-Process, and Final Inspection procedures.
• Ensures that the disposition of non-conforming materials meets all regulatory requirements and that corrective actions are adequate to prevent recurrence.