Supplier Quality Engineer
Supplier Quality Engineer
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Job Description
Job Title: Supplier Quality Engineer
Location: Gainesville FL (Onsite)
Job Description & Skill Requirement:
- 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 Suppliers 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 NCs within Trackwise.
- Own or support identified supplier CAPAs and manage to timely root cause investigationimplementation and closure.
- Communicate & collaborate with suppliers regarding non-conformances escalating suppliercorrective 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 qualityactivities.
- 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 toassigned suppliers
- Responsible for accuracy and integrity of supplier data that ensures compliance with documentedprocedures & processes.
- Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure allassigned supplier related material quality issues are effectively communicated to key stakeholders.
- Maintain structured communication channels with strategic sourcing identifying responsibility bycommodity / 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
Qualification:
- Bachelors 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
Employment Type
Full-time
