Quality Engineer

The Quality Engineer serves as a key quality assurance resource, providing hands-on support to ensure ongoing product manufacturing aligns with established quality and regulatory standards.

Requirements

• Identify and assist with process validation activities.
• Support projects related to manufacturing plant layout/process to ensure efficient and timely completion.
• Manage multiple projects in various stages of production, including, process improvements, quality inspections, and quarantine and inventory control.
• Lead risk management activities such as verification of risk mitigation implementation in products and processes (PFMEA).
• Assist with design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.
• Inspect product including labeling and documentation for release of finished goods.
• Assist with Operations and Engineering to ensure that all production employees are familiar with, trained on, and follow all manufacturing procedures related to their jobs
• Ensure that changes to procedures are reviewed, approved and validated prior to implementation.
• Oversee creation and review of documentation for nonconforming products.
• Provide quality engineering support and expertise in the investigation of nonconformances and CAPAs.
• Works with Engineering department ensuring that engineering change orders affecting production related changes are reviewed
• Keep management informed of significant issues identified during production-related quality activities as well as actions being taken to improve and correct the situation.
• Assist with revisions and updates to quality procedures, standardized work instructions
• Participate in supplier management activities. Identify supplier quality issues and report to management in timely manner.
• Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA etc.).
• Other duties as assigned.

Benefits

• Medical – 90% employer paid
• Dental – 100% employer paid
• Life Insurance, AD&D, STD & LTD Insurance – 100% employer paid
• Vision
• 401k Matching
• Paid Leave: Sick, Vacation and Holidays