Supplier Quality Engineer

DEKA Research & Development•Manchester, NH

21d

About The Position

The Supplier Quality Engineer is responsible for leading supplier quality activities during design transfer and process/product validation. This role ensures supplier compliance to applicable requirements, including 21CFR, ISO 13485, and drives supplier development and performance management processes. The SQE serves as a key technical and quality liaison between the DEKA design team and manufacturing partners with primary responsibility for ensuring suppliers are capable of consistently meeting quality, regulatory, and performance expectations. This role will heavily support process and tool validation support, while also managing sustaining supplier quality performance for production materials and services.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree.
3–5 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry
Strong knowledge of ISO 13485 and medical device regulatory requirements
Experience with supplier audits, qualification, and risk-based supplier management
Strong understanding of manufacturing processes, validation, and quality systems.
Experience with medical device manufacturing and global supply chains
Ability to interpret mechanical drawings
Familiarity with statistical tools (Minitab), risk analysis (FMEA), and CAPA systems
Experience in process and tool validation
Strong technical judgment and problem-solving skills
Ability to lead supplier interactions and drive accountability
Excellent communication and cross-functional collaboration skills
Strong root cause analysis and data-driven decision-making capability
Ability to manage multiple priorities in a fast-paced NPI and production environment
High attention to detail and regulatory compliance mindset

Nice To Haves

Experience supporting NPI or design transfer activities strongly preferred
ISO 13485 Internal Auditor certification preferred.
ASQ certifications (Supplier Quality Professional, Green Belt, CQE, CQA, or similar) are a plus.

Responsibilities

Review and approve supplier documentation including certifications, validations, and quality records
Ensure supplier readiness for production launch, including quality systems, and process controls
Participate in design transfer and process/tool validation activities such as IQ/OQ/PQ, MSA and Statistical analysis
Sustaining Supplier Quality Management
Supplier development and continuous improvement to ensure effective design transfer
Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
Lead/Support supplier corrective action activities (SCAR/CAPA) and ensure timely closure
Conduct supplier performance reviews and drive continuous improvement initiatives
Support containment, root cause analysis, and resolution of supplier-related quality issues
Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485
Support external and internal audits involving supplier quality systems
Drive adherence to change notification and supplier control requirements
Partner with Contract Manufacturing, Procurement, and Engineering
Support material nonconformance investigations and disposition decisions
Provide supplier risk input to project teams and change control processes
Support supply continuity and risk mitigation strategies
Writing Test Methods to support Validation