Job Description
Title: Supplier Quality Engineer
Location : Latham, NY
Domain: Medical Device industry.
Job Description
- 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.
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 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
- Experience with APQP (IQ,OQ,PQ) preferred.
- Technical writing of protocols and reports.
- Experience in ISO 9001, 13485 a plus.
- Ability to travel to supplier sites within assigned region.
- Looking for candidate who has extensive medical device domain industry experience.
Disclaimer: This job listing is sourced from LinkedIn and is provided for informational purposes. Apply directly through the employer’s application process. Medical Device Navigator is not affiliated with the hiring company.