The Senior Supplier Quality Engineer (Sr. SQE) is responsible for leading supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations. This role ensures supplier compliance to applicable requirements, including 21CFR, ISO 13485, and drives robust supplier qualification, development, and performance management processes.
The Sr. SQE serves as a key technical and quality liaison between DEKA, manufacturing partner and its supplier base, with primary responsibility for ensuring suppliers are capable of consistently meeting quality, regulatory, and performance expectations. This role will heavily support supplier qualification activities for NPI programs, including process validation support, and onboarding of new suppliers, while also managing sustaining supplier quality performance for production materials and services.
How you will make an impact as a Senior Supplier Quality Engineer
- 01Lead supplier qualification activities for New Product Introduction (NPI) projects
- 02Perform risk-based supplier assessments aligned with product and process criticality
- 03Support supplier selection decisions in collaboration with Design Authority (customer), Engineering, Procurement, and Quality Assurance
- 04Conduct supplier audits (remote and onsite) for new and existing suppliers
- 05Review and approve supplier documentation including certifications, validations, and quality records
- 06Ensure supplier readiness for production launch, including capacity, quality systems, and process controls
- 07Participate in design transfer and process validation activities where supplier input is required
Sustaining Supplier Quality Management
- 08Own supplier quality oversight for assigned NPI projects and production suppliers
- 09Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
- 10Lead supplier corrective action activities (SCAR/CAPA) and ensure timely closure
- 11Conduct supplier performance reviews and drive continuous improvement initiatives
- 12Support containment, root cause analysis, and resolution of supplier-related quality issues
- 13Perform risk-based supplier re-evaluations and periodic assessments
Supplier Quality System & Compliance
- 14Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485
- 15Maintain and improve Approved Supplier List (ASL) classification and risk-based controls
- 16Support external and internal audits involving supplier quality systems
- 17Ensure supplier quality agreements are established and maintained
- 18Drive adherence to change notification and supplier control requirements
Cross-Functional Collaboration
- 19Partner with Design Authority (customer), Procurement, Manufacturing and Engineering
- 20Support material nonconformance investigations and disposition decisions
- 21Provide supplier risk input to project teams and change control processes
- 22Support supply continuity and risk mitigation strategies
Skills you will need to be successful in this role
- 23Bachelor’s degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree.
- 243–5 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry
- 25Strong knowledge of ISO 13485 and medical device regulatory requirements
- 26Experience with supplier audits, qualification, and risk-based supplier management
- 27Experience supporting NPI or design transfer activities strongly preferred
- 28Strong understanding of manufacturing processes, validation, and quality systems.
Skills & Competencies
- 29Experience with contract manufacturing and global supply chains
- 30Ability interpret mechanical drawings (CAD files)
- 31Familiarity with statistical tools, risk analysis (FMEA), and CAPA systems
- 32Experience in lean manufacturing or continuous improvement environments
- 33Strong technical judgment and problem-solving skills
- 34Ability to lead supplier interactions and drive accountability
- 35Excellent communication and cross-functional collaboration skills
- 36Strong root cause analysis and data-driven decision-making capability
- 37Ability to manage multiple priorities in a fast-paced NPI and production environment
- 38High attention to detail and regulatory compliance mindset
- 39Willingness to travel both domestically and internationally to suppliers as needed, estimated to be 20% travel
Preferred Certifications
- 40ISO 13485 Internal Auditor certification preferred.
- 41ASQ certifications (CQE, CQA, or similar) are a plus.
Estados Unidos
