Description:
You will support Quality Control and Quality Assurance operations, playing a key role in ensuring the quality, compliance, and integrity of manufacturing processes. This role involves processing and analysing nonconformance events, supporting internal and external audits, reviewing and managing quality documentation, and working collaboratively with cross‑functional teams to ensure ongoing product quality. You may also contribute to the development and continuous improvement of quality assurance and quality control methods and procedures.
Essential Duties And Responsibilities (performance Expectations Vary By Level)
- You will support Quality Engineering activities, including Change Order processing, Nonconformance Events (NCEs), Nonconforming Material Reports (NCMRs), and CAPA investigations.
- You will collect manufacturing and inspection data and perform inspections to support investigations led by Quality Engineers.
- You will support production through regular presence on the manufacturing floor and assist the inspection team with questions related to inspection methods, processes, and specifications.
- You will support Quality Engineering in ensuring compliance with internal procedures and external standards and regulations, including GMP, GLP, ISO, and Six Sigma requirements.
- You will update and maintain quality assurance procedures, protocols, and methods for processing materials into partially finished and finished products.
- You must ensure manufacturing and production processes comply with internal quality systems and applicable safety, quality, and regulatory requirements to enable worldwide product distribution.
- You will support the investigation, assessment, verification, and disposition of nonconforming materials in collaboration with cross‑functional teams.
- You will perform routine line audits to verify that systems are compliant, effective, and operating as intended.
- You will provide day‑to‑day quality support to Quality Engineering and Operations by addressing production quality issues and supporting the implementation of corrective and corrective actions.
- You must identify opportunities for quality and process improvement and contribute to continuous improvement initiatives that enhance product quality and process efficiency.
- You must communicate any concerns related to work processes, environmental impact, health, or safety to your manager in a timely manner.
- You must read and interpret specifications, inspection criteria, and engineering drawings, applying requirements using appropriate and properly configured inspection tools.
- You will demonstrate sound decision‑making skills and the ability to work independently with minimal supervision.
- You may assist in the training and mentoring of junior technicians, as required.
- You must apply intermediate computer skills, including effective use of Microsoft Office applications.
- You must demonstrate excellent attention to detail and strong documentation practices. You will perform additional duties as assigned in support of Quality and Operations objectives.