Katalyst CRO
Overview
Supplier Quality Engineer role at Katalyst CRO. This role focuses on managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies and ensuring QMS compliance across supplier-related activities.
Responsibilities
Manage finished goods Contract Manufactured (CM) for Robotics Surgical Technologies.
Lead and support QMS activities related to supplier selection, supplier change requests, qualification, manufacturing, QMS development, and improvements in technical quality, service, and costs.
Collaborate 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.
Lead PPAP qualifications with CMs and collaborate to develop robust SCAPAs.
Support the Quality team to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.
Develop, implement, and monitor CM/supplier development initiatives, including CM performance management, CM certification, process improvements, cost reduction, supplier forums, Six Sigma/Lean integration, audits, and selection activities aligned with business goals.
Collaborate on New Product Development (NPD) teams to evaluate future CMs and their quality/development plans.
Build and own the strategy for managing CMs/Suppliers for the business and communicate CM initiatives, updates, and issues to the Quality lead.
Partner with Supplier Quality Managers to manage CMs across regions and ensure CM compliance with Quality Systems and internal procedures and policies.
Facilitate customer complaints for CM products and ensure adequate investigation and corrective actions by CMs; manage the Supplier Corrective Action Request program.
Develop and manage a strategy to address CM/supplier capability deficiencies and ensure proper approval and documentation for any SCR changes at CMs.
Grow effective partnerships with preferred CMs to drive optimal performance based on trust, loyalty, and cost/quality outcomes.
Lead by example with a continuous-improvement mindset and a strong quality culture.
Maintain compliance with defined Key Performance Indicators and maintain high standards of compliance and operational excellence.
Manage and report on CM supplier audit programs 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 experience.
Change requests experience.
Supplier evaluations experience.
Qualifying component changes; CAPA, TMV, Control plans, PFMEA.
ISO13485 & GMP experience.
Robotics experience is a plus.
Seniority level
Associate
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO.
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Responsibilities
Manage finished goods Contract Manufactured (CM) for Robotics Surgical Technologies.
Lead and support QMS activities related to supplier selection, supplier change requests, qualification, manufacturing, QMS development, and improvements in technical quality, service, and costs.
Collaborate 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.
Lead PPAP qualifications with CMs and collaborate to develop robust SCAPAs.
Support the Quality team to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.
Develop, implement, and monitor CM/supplier development initiatives, including CM performance management, CM certification, process improvements, cost reduction, supplier forums, Six Sigma/Lean integration, audits, and selection activities aligned with business goals.
Collaborate on New Product Development (NPD) teams to evaluate future CMs and their quality/development plans.
Build and own the strategy for managing CMs/Suppliers for the business and communicate CM initiatives, updates, and issues to the Quality lead.
Partner with Supplier Quality Managers to manage CMs across regions and ensure CM compliance with Quality Systems and internal procedures and policies.
Facilitate customer complaints for CM products and ensure adequate investigation and corrective actions by CMs; manage the Supplier Corrective Action Request program.
Develop and manage a strategy to address CM/supplier capability deficiencies and ensure proper approval and documentation for any SCR changes at CMs.
Grow effective partnerships with preferred CMs to drive optimal performance based on trust, loyalty, and cost/quality outcomes.
Lead by example with a continuous-improvement mindset and a strong quality culture.
Maintain compliance with defined Key Performance Indicators and maintain high standards of compliance and operational excellence.
Manage and report on CM supplier audit programs 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 experience.
Change requests experience.
Supplier evaluations experience.
Qualifying component changes; CAPA, TMV, Control plans, PFMEA.
ISO13485 & GMP experience.
Robotics experience is a plus.
Seniority level
Associate
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO.
#J-18808-Ljbffr