Manufacturing quality engineering

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.

How you will make an impact as a Supplier Quality Engineer:

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

Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)

Conduct supplier performance reviews and drive continuous improvement initiatives

Support containment, root cause analysis, and resolution of supplier-related quality issues

Supplier Quality System & Compliance

Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485

Support external and internal audits involving supplier quality systems

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

Bachelor’s degree in Engineering, Life Sciences, or related technical field; 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

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

Willingness to travel both domestically and internationally to suppliers as needed, estimated to be 20% travel

ASQ certifications (Supplier Quality Professional, Green Belt, CQE, CQA, or similar) are a plus.