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:
- Lead supplier qualification activities for New Product Introduction (NPI) projects
- Perform risk-based supplier assessments aligned with product and process criticality
- Support supplier selection decisions in collaboration with Design Authority (customer), Engineering, Procurement, and Quality Assurance
- Conduct supplier audits (remote and onsite) for new and existing suppliers
- Review and approve supplier documentation including certifications, validations, and quality records
- Ensure supplier readiness for production launch, including capacity, quality systems, and process controls
- Participate in design transfer and process validation activities where supplier input is required
- Own supplier quality oversight for assigned NPI projects and production suppliers
- Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
- Lead 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
- Perform risk-based supplier re-evaluations and periodic assessments
- Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485
- Maintain and improve Approved Supplier List (ASL) classification and risk-based controls
- Support external and internal audits involving supplier quality systems
- Ensure supplier quality agreements are established and maintained
- Drive adherence to change notification and supplier control requirements
- Partner with Design Authority (customer), Procurement, Manufacturing 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; 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
- Experience supporting NPI or design transfer activities strongly preferred
- Strong understanding of manufacturing processes, validation, and quality systems.
- Experience with contract manufacturing and global supply chains
- Ability interpret mechanical drawings (CAD files)
- Familiarity with statistical tools, risk analysis (FMEA), and CAPA systems
- Experience in lean manufacturing or continuous improvement environments
- 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
- Willingness to travel both domestically and internationally to suppliers as needed, estimated to be 20% travel
- ISO 13485 Internal Auditor certification preferred.
- ASQ certifications (CQE, CQA, or similar) are a plus.
Skills Required
- 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
What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester. DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality. DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
