Beschreibung
• As a team leader, participate and coordinate with the engineering and procurement activities to identify strategic suppliers and their associated risks, including facilitation of systemic techniques and quantitative analysis.•Assist in the identification of significant variables and develop/author supplier quality control plans.
• Drive proactive continuous improvement efforts in quality performance.
• Lead the execution of supplier development and quality control plans.
• Ensure metrics for supplier quality are developed, maintained and reviewed to promote continued and/or sustained success.
• Interfaces with Customer on supplier issues, as required.
• Conceives, proposes, and sells new ideas, strategies, or concepts, and guides those projects to completion.
• Makes and takes responsibility for decisions that have wide-impact.
• Drive discussion across the organization and consider the implications of their work within the scope of the company.
• Oversee the planning process and delegation across teams and/or departments.
• Quality oversight of internal and external process characterization project plans, protocols, and reports.
• Activities to include authoring, issuance, and review of regulated documents and ensure processes and products comply with current Good Manufacturing Practices and 21 CFR 820.
• Knowledge of cGMP, FDA/EMA regulations.
• Support regulatory inspections by FDA and foreign regulatory agencies.
• Other duties as needed.
•Practical experience with ISO 13485, FDA Quality System Regulations, Good Manufacturing Practices, Good Documentation Practices, ISO 14971, and other applicable standards.
• Working knowledge of principles, concepts, and practices for design and development activities, Risk Management, FDA 510K submissions, and ISO Regulations.