What are the responsibilities and job description for the Principal Supplier Quality Engineer position at Katalyst CRO?
Job Description
- This person must be able to travel 5-10% globally (possibly Sweden, China, Finland, also local.) Approximately 5-10 trips per year.
- As a Principal Supplier Engineer, you'll be the bridge between Boston Scientific Cardiac Diagnostics (CDx) cutting-edge design leading the integration of new and existing technologies into CDx's global supply chain.
- Your work will directly impact the reliability, scalability, and speed at which life-changing devices reach patients.
- As the technical lead, you'll work with R&D, Quality, Operations, and Regulatory team members to integrate OEM and sub-system supplier designs along with supplied components into CDx's products to ensure compliance, performance, and safety requirements are met.
- This role has a wide scope of responsibilities ranging from ensuring supplier design assurance, supplier product development integration assurance, and third-party manufacturing assurance.
- Working with Medical Device OEM, sub-system and component suppliers to identify supplier specifications with the end goal of successfully integrating supplied designs and components into CDx's development and manufacturing processes.
- Partnering with R&D, Design Assurance, Manufacturing Engineering, Operations Quality, and Project Management to execute supplier control deliverables according to program needs, such as purchased material qualifications, supplier-driven change assessments, supplier design or capability improvement projects, or regulated compliance assessments.
- Generating and reviewing quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
- Investigating complaints and managing supplier investigations for both design and manufacturing-related issues.
- Participating in supplier audits to assess design and manufacturing compliance to regulatory standards and CDx agreed specification requirements. Audit activities include the evaluation of audit observations and findings, reporting, follow-up, and confirmation of follow-up actions.
- Acting as a technical expert to ensure repeatable and reproducible quality/reliability during the life of the product.
- Bachelor's degree in engineering or related discipline.
- 7 years of technical experience working in Medical Device development processes.
- Experience in design controls, risk management, process validation, and CAPA.
- Design Assurance experience.
- Component and supplier qualification experience.
- Strong Project Management skills.
- Auditor of ISO 13485 quality systems (ISO 13485 Certified Auditor preferred).
- Self-driven and results oriented with strong data analytics and critical thinking skills.
- Experience managing projects and working with cross-functional teams to drive deliverables.
- Experience working with suppliers and familiar with the application of design controls and supplier controls as per 21CFR820 and MDR.
- Supplier design assurance, supplier product development integration assurance, and third-party manufacturing assurance.