Quality Engineer

Responsibilities :

• A minimum of Technical / Engineering Degree with + years of related experience Medical Device Supplier Quality domain.?
• Working knowledge of regulatory compliance requirements ( Quality System Regulations (QSRs),
• Medical Device Directive (MDD), ISO , ISO , ISO or other international standards)
• required? Provides overall quality assurance leadership in the management of Direct,
• Indirect Suppliers and / or External Manufacturers engaged in the production of Pharmaceutical products.?
• Leads the deployment of the Supplier Quality Management (SQM) strategies and associated standards, policies,
• procedures, programs, systems, processes, and initiatives for suppliers of the CSS supply chain..?
• Collaboration with suppliers for documentation and experience in onboarding suppliers in the ASL system.?
• Support trainings for the stakeholders? Collaborate with Strategic Sourcing / Procurement, R&D, Engineering / Technical Operations, Quality, Operations, business partners / stakeholders, and external suppliers to implement solutions and improve suppliers?
• quality and overall service and performance.? Supports the execution of plans / strategies, and implementation of systems, processes, and procedures to ensure robust supplier / purchasing controls with regards to the determination, selection, qualification,
• monitoring, and disengagement of suppliers.? Excellence (PEx) tools in support of supplier-related changes, risk management,?

Product / process transfers, innovations, and continuous process enhancements to improve supplier reliability, minimize risks, and ensure sustainable sources of material supply capable of meeting or exceeding Quality, Compliance, and Business requirements

Requirements :

• A minimum of years of experience in Quality Engineering or Quality Assurance,including data analysis, risk assessment and risk mitigation is required.
• Working experience in good manufacturing practice regulated environment is preferred(medical device, pharmaceutical, etc.).
• Under ( limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws / regulations and Corporate Pharmaceutical, procedures and guidelines, this position : ?
• Provide timely business support for the assigned CSS Supplier Quality Management (SQM) function globally.? Lead, develop, and implement supplier / purchasing controls and associated activities including Approved Supplier List management.?
• Participate in and / or support the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management.
• May lead this process under the guidance of Supplier Quality Manager and / or management representative.?
• Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.
• Partner with Procurement, R&D, Engineering / Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution / prevention of supplier-related issues to minimize / prevent business disruptions.?
• Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
• Implement supplier change management
• process including change notification,? dissemination of information, impact assessment, approval of changes, and supports material / supplier qualifications.?
• Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision.

Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects.?

Apply appropriate Quality Engineering and PEx tools ( PM / VSM, Kaizen,? DMAIC, FMEA / FTA, RCA, MSA, SPC, Cp / Cpk / Cpm / Ppk, Hypothesis Testing, ANOVA / DOE / EVOP, etc.

to support innovations and continuous improvements.? Comply with all applicable quality management system, environmental, safety and occupational health policies.

for example, ISO , ISO & OSHAS).? Responsible for communicating business related issues or opportunities to next management level.

Take part in making decisions on selection of suitable team based on the project needs in concurrence with the customer?

Meet delivery promise in terms of budget and timescales? Monitor project progress and team performance and make necessary changes to the team as needed to ensure achievement of project goals?

• Work within a multi-discipline team? Responsibility for team and cross-functional communications;
• lead phase and business reviews, project meeting minutes, issues log, metrics, and other key communications
30+ days ago