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Supplier Quality Engineer
Job Location:
Job Location:
Manchester - UK
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
1 September 2026 (5 hours ago)
Posted:
Application Deadline:
29 November 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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:
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
- 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
- Bachelors degree in Engineering Life Sciences or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree.
- 35 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 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
- Willingness to travel both domestically and internationally to suppliers as needed estimated to be 20% travel
- ISO 13485 Internal Auditor certification preferred.
- ASQ certifications (Supplier Quality Professional Green Belt CQE CQA or similar) are a plus.
Required Experience:
Manager
About Company
DEKA Research and Development is perhaps best known for its founder and president Dean Kamen -- and for the Segway Personal Transporter he invented. DEKA is a design and engineering firm that develops innovative technologies, many of them in the field of medical devices. The Segway it ... View more
