Aroha Technologies, Inc · 3 hours ago
Supplier Quality Engineer
Latham, NY
Contract
Onsite
Mid, Senior Level
4+ years expAroha Technologies, Inc is seeking a Supplier Quality Engineer to implement quality engineering processes and drive supplier improvement initiatives. The role involves evaluating suppliers, ensuring compliance with regulatory requirements, and managing supplier quality systems.
Software
No H1B
Responsibilities
Implement Quality Engineering, Purchasing Controls, and Supplier Quality processes related to the development, procurement, and continuous improvement of manufacturing materials, components, software, sub-assemblies, contract manufactured finished devices, products, or services
Evaluate suppliers' critical quality processes and ensure compliance with regulatory requirements and procedures
Drive supplier improvement via SQIPs (Supplier Quality Improvement Plans) and lead the Supplier Change Notice process with support from Engineering, Quality Engineering, Assurance
Qualify suppliers, assess their metrics, and audit their critical quality processes
Ensure validations are completed where specified and control plans exist to ensure sustained quality and compliance of supplied raw materials and components
Independently Produces and completes Supplier Quality Engineering related activities and documentation
Completes Qualification of materials and components (including spare parts), development/ improvement of supplier processes for CtQ's, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met
Qualifies and sustains sub- processes of suppliers, including performing process validations for critical supplier processes impacting part quality
Ensures that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (APQP / PPAP), and SQ audit results
Executes SCAR management, effective and timely closure Regulatory, ME, R&D, Clinical, etc
Experience in leading process improvement methodologies and organizational change management
Proven record of accomplishment in developing suppliers and implementing lean methodologies at supplier end
Develop and support regulatory compliance gaps at suppliers, including supplier quality system and process development activities
Manage additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records
Ensure raw materials/components/products at supplier(s) are released from supplier(s) according to the agreed requirements
Perform 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE)
Drive quality and compliance development and/or improvement at suppliers when needed
Qualification
Required
Bachelor's degree in engineering or science discipline, or equivalent experience
A minimum of 4 to 8 years of experience in establishing and maintaining regulated supplier management systems
Engineer quality and ensure compliance for raw materials, components, finished products etc
Certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer(CQE) and Certified Quality will be advantage
Any Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course will be added advantage
Excellent communication skills in English (written and verbal)
Demonstrated experience in collaborative working environments, conflict resolution, and stakeholder influencing
Ability to drive progress, take initiative, and achieve results
Experience with technical drawings, specifications of parts
Experience in Manufacturing process of welding, soldering, crimping, injection molding, plating, casting, and thermal forming
Ability to travel to supplier sites within assigned region
Preferred
Experience with APQP (IQ,OQ,PQ) preferred
Experience in ISO 9001, 13485 a plus
Look candidates from Medical Device Manufacturing Industry
Company
Aroha Technologies, Inc
AROHA is a leading global provider of end-to-end, technology-enabled business solutions, including ERP, SCM, PLM, WMS, CRM, portal, e-commerce, application development, project services, e-learning, training, staffing, call center, and global sourcing solutions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
SATHEESH CHAND RAAVI
Chief Operating Officer
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