Sr Supplier Quality Engineer

Karwell Technologies

St Paul, MN

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JOB DETAILS

SKILLS

Auditing, Cardiology, Code of Federal Regulations, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Design Verification, ISO (International Organization for Standardization), Maintain Compliance, Manufacturing, Manufacturing Analysis, Manufacturing Engineering, Manufacturing Operations, Manufacturing Requirements, Manufacturing/Industrial Processes, Medical Equipment, OEM (Original Equipment Manufacturer), Process Improvement, Process Validation, Product Development, Productivity Management, Project/Program Management, Purchasing/Procurement, Quality Engineering, Quality Management, Regulations, Regulatory Compliance, Research & Development (R&D), Risk Management, Safety Training, Software Design, Supply Chain, System Integration (SI), Technical Leadership, Third-Party Payer, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Selection

LOCATION

St Paul, MN

POSTED

30+ days ago

Job Description:

As a Senior Supplier Engineer, you'll be the bridge between Cardiac Diagnostics (CDx) cutting-edge design leading the integration of new and existing technologies into CDx's global supply chain.
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.

Responsibilities:

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.

Requirements:

Bachelor's degree in engineering or related discipline.
Minimum 5 years of technical experience working in Medical Device development processes.
Experience in design controls, risk management, process validation, and CAPA.
Experience working with external OEM suppliers (meaning suppliers with their own cleared medical devices), including the integration of design controls between the OEM supplied medical device and CDx's system design controls.
Design assurance experience with 5+ years working in Medical Device development.
Experience working with suppliers and familiar with the application of design controls and supplier controls as per 21CFR820 and MDR.
Auditor of quality systems experience (ISO 13485 or similar).
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.

Skills Need:

BS Engineering and 5+ years of medical device industry experience.
Design controls, risk management, Process Validation and CAPA required.
Design Assurance.
ISO 13485 Certified Auditor.
Project Management.
Supplier design assurance, supplier product development integration assurance, and third-party manufacturing assurance.
Component and supplier qualification.
Working with external OEM suppliers (meaning suppliers with their own cleared medical devices), including the integration of design controls between the OEM supplied medical device and CDx's system design controls.

About the Company

Karwell Technologies

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