Quality Engineer

Company : Katalyst Healthcares & Life Sciences

Responsibilities:

• The Supplier Quality Engineer is responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies.
• Primary duties are focused on all QMS related matters pertaining to supplier selection, processing supplier change request, qualification, manufacturing, QMS development, and technical quality/service/costs improvements.
• Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, SPC, SCR, Quality Plans, Control Plans, and FMEAs.
• Represent the supplier quality engineering function to develop and execute the strategy to organize, direct, and report on all CM quality-related activities for contracted design and manufactured items made for the business.
• Lead PPAP qualifications with the CMs.
• Collaborate with CMs to develop robust SCAPAs.
• Support the Quality team (member of) to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.
• Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, SPC, Quality Plans, Control Plans, and FMEAs.
• Develop, implement, and monitor CMs/Supplier's development initiatives, including CM performance management, CM certification, process improvements, cost reduction, supplier forums, Six Sigma/Lean integration, audits, and selection activities, that align with the C&RM or/and business strategic goals and objectives.
• Collaborate on New Product Development (NPD) teams to evaluate and understand future CMs and their associated quality and development plans.
• Build and own the strategy for managing the CMs/Suppliers for the business.
• Communicate with the business Quality lead on CM initiatives, updates, and issues.
• Partner with Supplier Quality Managers to build a strategy for managing the CMs in all regions.
• Ensure CM compliance with business Quality Systems and all relevant internal procedures and policies.
• Facilitate customer complaints for CM products and ensure adequate investigation and corrective actions are taken by CMs.
• Manage Supplier Corrective Action Request program to ensure consistency in handling corrective actions by CMs.
• Develop, communicate, and manage a strategy/plan for addressing finished goods CMs/Suppliers capability deficiencies, etc.
• Ensure proper approval and documentation practices are followed for any process, material or tooling change (SCR Supplier Change Request) at CMs.
• Define and manage the process for growing effective "partnerships " with preferred CMs (to drive optimal performance) founded on common interest and which demonstrate trust, loyalty and financial success.
• Lead by Example: Setting continuous-improvement driven mentality and solid quality culture for the organization.
• Maintain compliance to set Key Performance Indicators for the business.
• Maintain the highest level of compliance and operational standards set by the business.
• Manage and report on CMs/Suppliers audit program in line with ISO and/or FDA 21 CFR part 820 regulations.

Requirements:

• BS Engineering.
• 3+ years of Medical Device experience.
• PPAP experience.
• Process improvements.
• Change requests.
• Supplier evaluations.
• Qualifying component changes.
• CAPA, TMV, Control plans, PFMEA.
• ISO13485 & GMP.
• Robotics experience.

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