Beschreibung
Hi Greetings from UBIQUE Systems!Hope you're doing Good!
Glad to reach you for “Supply Quality Engineer” role.
Please go through the JD below, if interested send your updated CV (English) together with your availability and expected yearly/daily rate to proceed.
Location: Munich, DE/ Remote Work
Duration: Fixed Term Contract or 12+ months (can be extended)
Rate: Open to discuss
Start Date: Feb 2022
Languages: English and German
Job Description:
Key Areas of Responsibility:
• 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.
• 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 program – 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
Basic Qualifications:
o Bachelor’s Degree
o 5+ years' experience in quality, engineering, manufacturing, or highly regulated environment
Thank you!
Best Regards
Stephen Lamater. S | Delivery Team | UBIQUE Systems
Phone : | Email : | Web : www.ubique-systems.com
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