Quality Engineer - cleanpac

The Quality Engineer assists and operates under the direction of the QA/RA Manager, or designee. The Quality Engineer must support proper cleanroom operations, including gowning before entry and maintaining a clean work environment. Tasks may include Quality document creation and updates, managing CAPA investigation, oversight of NCRs, process validation assistance, supplier management, and training associates to an electronic quality system. Other duties may develop over time based on business needs and availability.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Adhere to the Quality Management System and support all quality initiatives.
• Create, update, and maintain Quality system documents.
• Manage CAPA investigations through documentation and track Root Causes.
• Responsible for the oversight of nonconforming material to include reports, Material Review Board (MRB), and proper disposition of product.
• Assist with Process Validations including protocols, reports, and applicable risk management activities as necessary to support Manufacturing and Quality.
• Evaluate and qualify new suppliers through audits, assessments, and documentation reviews.
• Support ongoing supplier monitoring activities, including performance tracking, scorecards, and risk assessments.
• Maintain supplier quality records, certifications, and compliance documentation.
• Implement and maintain eQMS system.
• Train all employees on eQMS system.
• Provide review and submit correction of quality documents as needed within the Quality inspection process.

QUALIFICATIONS:

• Experience with ISO 13485 or similar quality systems.
• Must be detail oriented, able to follow directions, and adhere to procedures in a structured work environment.
• Ability to complete tasks independently without constant supervision.
• Proficiency in Microsoft Windows and Office applications (e.g., Word, Excel, PowerPoint, Access) required.
• Ability to interact with colleagues and suppliers in a professional manner.
• Good problem-solving and analytical skills.
• Ability to understand and follow directions, complex policies, and procedures.
• Must be able to work in a cleanroom environment utilizing required garments and PPE.
• Communicate quality or compliance concerns with urgency.
• Strong interpersonal oral and written communication skills with the ability to communicate with urgency.

EDUCATION and EXPERIENCE:

• Bachelor's degree required, and or combination of experience.
• Minimum 2 years' experience in an FDA regulated environment is preferred.
• Experience in a document change control environment or administrative experience required
• Cleanroom gowning experience preferred.