Supplier Quality Engineer

Latham, NY - USA

Monthly Salary: Not Disclosed

Posted on: 13 hours ago

Vacancies: 1 Vacancy

Job Summary

Role: Supplier Quality Engineer

Location : Latham NY

Key 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 CtQs 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 to 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.

Required Skills and Qualifications:

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 advantageous.
Any Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course will be an 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
Experience with APQP (IQOQPQ) preferred.
Technical writing of protocols and reports.
Experience in ISO a plus.
Ability to travel to supplier sites within assigned region.

Role: Supplier Quality Engineer Location : Latham NY Key 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 contrac...

Role: Supplier Quality Engineer

Location : Latham NY

Key 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 CtQs 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 to 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.

Required Skills and Qualifications:

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 advantageous.
Any Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course will be an 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
Experience with APQP (IQOQPQ) preferred.
Technical writing of protocols and reports.
Experience in ISO a plus.
Ability to travel to supplier sites within assigned region.