Senior Engineer, Quality Process

Preferrednice to have

• Proficient in understanding of Med Device manufacturing processes, ISO 13485, GMP.
• Lean Six Sigma training is a distinct advantage.
• Excellent communication skills and attention to detail.
• Proficient understanding of engineering and quality principles, including Risk Management, CAPA, Audits, and Statistics
• High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Confident representing Quality in cross-functional settings
• Self-starter able to manage multiple tasks in a fast-paced environment
• Willing to work as part of a multi-site team; some travel required

• Work closely with operations and the business functions to ensure quality performance of product and processes
• Collaborate cross-functionally with internal and external teams to resolve quality issues
• Manages internal and supplier-driven Non-Conformances (NCs), ensuring timely investigation and closure
• Owns Corrective and Preventive Actions (CAPAs) through root cause analysis to closure
• Disposition of non-conforming product through MRB, issuing NCs as appropriate
• Initiates and leads in the development and improvement of the manufacturing processes for existing and new products.
• Review and approval of change management activities, challenges change effectiveness and drives strong review.
• Interpret KPI trends, act as necessary, driving a continuous improvement process.
• Support the execution and analysis of manufacturing complaints and product field actions
• Provide QA support during internal and external audits
• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
• Proficient in risk management practices and concepts and applies knowledge to manufacturing operations and identify opportunities and weaknesses
• Lead and participate in the Lean philosophy – standardization and elimination of waste
• Understanding of Human Error Prevention and the application of those principles to the manufacturing environment.
• Support process/equipment validation, qualification, and Measurement System Analysis (MSA)
• Support with product holds and executing containment plans
• Manage supplier relationships, including but not limited to, coordinating communications, monitoring performance, managing in house and external nonconformities and ensuring timely delivery of quality materials and services.