Responsibilities:

• Knowledge of application of Regulatory requirement including ISO 13485, FDA and International requirements.
• Enhanced quality system requirements (QSR) throughout business unit by improving quality process and CAPA Closure.
• Implementing SICR- Supplier Initiated Change Requests (DCR, ECR, MCR) through Change management Process and as per ISO 13485 & CFR 21 Part 820 requirements.
• Presenting Supplier Initiated Change Requests to Change Management Board (CMB) for review & Approval.
• Review and Closure of Supplier Audit Non-Conformities as per NC & CAPA management System (Track wise).
• Review of Supplier deliverables like MSA, SPC, GD&T, Process Validation, PPAP, FMEA etc.
• Conducting Supplier’s Pre-Assessment Audits with Sourcing & RAQA Leads.
• Implementing Change Control Agreement (CCA), Audit Adoption, Self-Assessment Audit and Onsite Audit through organization procedure.
• Collaborates with cross-functional and suppliers’ teams to address top quality issues.
• Own identified supplier driven non-conformances and manage the timely closure of NC’s within Trackwise.
• Own or support identified supplier CAPAs and manage to timely root cause investigation, implementation and closure.
• Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
• Participates and may lead in the creation and/or review of new or modified procedures.
• Maintain KPIs for monitoring of supplier quality processes, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
• Applies statistical methods of analysis and process control to external operations.
• Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
• Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
• Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers
• Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes.
• Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders.
• Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity /supplier.
• Deliver continuous improvement activities focusing on supplier quality.
• Participate in supplier audit programs – planning, execution and closure.
• Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.
• Ability to collaborate effectively with lead cross functional team

Requirements:

• Bachelor’s Degree in Engineering or Science-related field.
• 5+ years’ experience in quality, engineering, manufacturing, or highly regulated environment.
• Fluent in written, oral in English and Understanding of US and International Medical Device Regulations.
• Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics).
• Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
• Strong interpersonal skills, written, oral communication and negotiations skills.
• Strong in critical thinking and “outside the box " thinking.
• Highly developed problem-solving skills. Strong analytical skills.
• Demonstrated ability to work independently and as part of cross-functional teams French.

• Knowledge of application of Regulatory requirement including ISO 13485, FDA and International requirements.
• Enhanced quality system requirements (QSR) throughout business unit by improving quality process and CAPA Closure.
• Implementing SICR- Supplier Initiated Change Requests (DCR, ECR, MCR) through Change management Process and as per ISO 13485 & CFR 21 Part 820 requirements.
• Presenting Supplier Initiated Change Requests to Change Management Board (CMB) for review & Approval.
• Review and Closure of Supplier Audit Non-Conformities as per NC & CAPA management System (Track wise).
• Review of Supplier deliverables like MSA, SPC, GD&T, Process Validation, PPAP, FMEA etc.
• Conducting Supplier’s Pre-Assessment Audits with Sourcing & RAQA Leads.
• Implementing Change Control Agreement (CCA), Audit Adoption, Self-Assessment Audit and Onsite Audit through organization procedure.
• Collaborates with cross-functional and suppliers’ teams to address top quality issues.
• Own identified supplier driven non-conformances and manage the timely closure of NC’s within Trackwise.
• Own or support identified supplier CAPAs and manage to timely root cause investigation, implementation and closure.
• Communicate & collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required.
• Participates and may lead in the creation and/or review of new or modified procedures.
• Maintain KPIs for monitoring of supplier quality processes, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
• Applies statistical methods of analysis and process control to external operations.
• Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
• Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
• Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers
• Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes.
• Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders.
• Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity /supplier.
• Deliver continuous improvement activities focusing on supplier quality.
• Participate in supplier audit programs – planning, execution and closure.
• Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.
• Ability to collaborate effectively with lead cross functional tea