Full-Time

The Quality Assurance / Quality Control Specialist primary functions include maintaining quality standards by approving incoming materials, in-process production, finished products, and recording accurate, detailed records, in a fast-paced environment. The role will also assist the Quality Lead with maintaining the Quality Management System by assisting with monitoring the Corrective and Preventive Action System, the Nonconforming Product system, Supplier Corrective Action System, the complaint system, Document Control, etc. This role exhibit a strong aptitude for engaging with and communicating both internal and external customers of any quality concerns, discrepancies, or issues.

Essential Functions:

• Responsible for providing general quality assurance support in the areas of inspection and manufacturing as well as maintaining the Quality Management System.

• Perform mechanical and visual inspection of manufactured product and/or processes per Mainstream documentation (drawings, specifications and procedures) and industry standards.

• Work in semi-structured assignments that requires adherence to defined procedures, regulations/standards, and/or specific, detailed instructions.

• Have the authority to accept or reject materials, subassemblies, assemblies and processes that affect the quality and safety of Mainstream products.

• Demonstrate strict adherence to all quality system procedures and manufacturing instructions.

• Read and understand schematics and mechanical drawings.

• Use measuring tools, such as rulers, gauge pins and calipers to inspect materials, components and fixtures.

• Accurately document all work performed on inspection reports.

• Work with manufacturing to ensure materials are properly segregated, traceability and identification are maintained throughout facility.

• Perform Quality review of documents related to QC testing, receiving inspection, product release activities, and other Quality Management System documents as required.

• Responsible for recognizing quality issues and communication to quality/management.

• Conduct and document investigations to determine the root cause(s) of the issue.

• Monitor and drive completion of actions for both internal and external customers.

• Perform special projects and other duties as assigned.

Position Requirements:

• A degree in quality or manufacturing engineering (or a related field) is preferred, or a combination of practical and on the job experience in the inspection or quality assurance industry is required.

• Preferred experience: Quality assurance and inspection experience in the Medical Device packaging field. Other regulated industries will also be considered.

• Demonstrated experience working within FDA-regulated quality systems and strong knowledge of QSR requirements.

• Understanding of technical product drawings, quality guidelines, process flow of inspection, and non-conformance handling.

• Proficiency with Microsoft Office.

• Well-developed written and oral interpersonal skills.

• Detail-oriented with excellent organizational skills