Dale WorkForce Solutions · 12 hours ago
Supplier Qualification Engineer � Imaging Medical Devices
Latham, NY
Full-time
Onsite
Senior Level
7+ years expDale WorkForce Solutions is seeking a highly motivated Supplier Qualification Engineer to support supplier qualification and ongoing compliance activities for imaging medical devices. This role involves working closely with suppliers and internal teams to ensure that processes and materials meet regulatory and quality standards throughout the product lifecycle.
Bookkeeping and PayrollConsultingRecruitingStaffing Agency
Responsibilities
Lead and support supplier qualification, onboarding, and re-qualification activities for components, assemblies, and critical processes used in imaging medical devices
Plan and execute supplier audits, including gap assessments, process capability reviews, and compliance evaluations aligned with ISO 13485 and applicable regulatory requirements
Review and approve supplier documentation, including process flows, PFMEAs, control plans, validation protocols, and quality agreements
Support process validation activities (IQ/OQ/PQ) at supplier sites for manufacturing and special processes
Collaborate with Manufacturing Engineering, R&D, and Quality teams to ensure design transfer and supplier readiness for NPI and sustaining programs
Drive supplier corrective and preventive actions (SCAR/CAPA) and verify effectiveness
Monitor supplier performance metrics (quality, delivery, compliance) and support continuous improvement initiatives
Ensure supplier controls align with risk management requirements (e.g., ISO 14971 where applicable)
Support regulatory inspections and internal audits related to supplier controls and external manufacturing
Qualification
Required
Bachelor's degree in Engineering or a related technical discipline
7+ years of experience in Supplier Quality Engineering, Manufacturing Engineering, or related roles within the medical device industry
Strong working knowledge of ISO 13485 and supplier control requirements
Hands-on experience with supplier audits, process qualification, and validation activities
Familiarity with regulated manufacturing environments and quality systems
Strong analytical, documentation, and communication skills
Ability to work cross-functionally and directly with external suppliers
Preferred
Experience supporting imaging medical devices or complex electromechanical systems
Knowledge of FDA QSR (21 CFR Part 820) and EU MDR supplier requirements
Experience with NPI supplier qualification and design transfer
Certification such as ASQ CQE, CQA, or equivalent
Experience working with global suppliers and contract manufacturers
Company
Dale WorkForce Solutions
Dale Workforce Solutions is a staffing and talent solution firm that provides staffing, on-demand consultation and payroll services.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Jamie Promislo
VP, Client Partnerships
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