Quality Assurance Engineer

Overview

Position would require the candidate to be a W2 employee of Donatech. US Citizenship Required.

• Plans, organizes, directs and reports on all supplier quality related activities such as raw materials, packaging materials, GMP service providers, as well as contract manufacturers, and laboratories to assure fulfillment of contract, purchase order requirements.
• Ensure control of supplier nonconforming items, conducts analyses and monitor effectiveness of corrective actions.
• Translates engineering, manufacturing, and quality requirements.
• Develops, modifies, applies, and maintains quality evaluation and control systems and protocols for processing materials into partially finished or finished materials product.
• Collaborates with internal engineering and manufacturing functions and external suppliers to ensure quality standards are in place.
• Monitors quality control activities and systems at supplier and subcontractor facilities and maintains feedback loops.
• Perform source surveillance & validation at source inspections, audit third party manufacturers, special process auditing as an approved corporate surveyor including their Sub-Tier suppliers/Sub-contractors, due diligence, and vendor selection process.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Prepares, maintains, and reviews procurement quality assurance procedures to assure compliance with customer and/or government requirements.
• May be certified in lean and six-sigma quality engineering methodologies.
• To review and update regularly and ensure all active Suppliers Sub-contractors’ approvals are within their expiry dates, or obtain new updated approval certificates.
• Review and approve or reject New Capability Requests for new Suppliers Subcontractors, check and challenge their accreditation certification.