Supplier Quality Engineer

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Supplier Quality Engineer’s primary responsibility is to manage assigned supplier relationships and quality program deliverables. Provides oversight, evaluation, and corrective action of all production and supplier quality related issues for external supplier processes and suppliers based on commodity class assigned. Generates reports, memos, files, and presentations necessary to manage the issues according to site procedures.

Role Responsibilities

• Primary Quality contact for assigned suppliers within an assigned commodity class.
• Responsible person for Quality Tracking System (Trackwise) records within Change Management, Investigations, SCAR, and Commitment Tracking modules ensuring timely completion and appropriate documentation of work completed in support of the record closure.
• Reviews and approves supplier change notifications, investigations, and corrective actions.
• Ensures component and tooling qualification activities are completed and meet SOP requirements.
• Issues Supplier Corrective Action Request (SCAR) and reviews/approves SCAR responses.
• Coordinates activities cross-functionally (QA, Operations, Purchasing, Product Design & Development) to ensure appropriate prioritization of deliverables, by the QE as well as the supplier.
• Ensure compliance with company procedures, quality standards, and government regulatory requirements.
• Responsible for review, redline and changes for assigned supplier quality plan (SQP), QC Test Report (QCTR) and controlled drawings.
• Owner for assigned projects, responsible for project management and task execution.
• Assists in identifying root causes and coordinates corrective action to quality issues.
• Ensures product or component traceability and quarantine as necessary.

 Basic Qualifications

• BS in an a scientific/engineering discipline.
• 2+ years of cGMP industry experience.
• Knowledge of computerized systems (MS Office suite).
• Fundamental understanding of statistical analysis utilizing software
• Demonstrated ability to manage multiple priorities.

Preferred Qualifications

• Experience within medical device or quality engineering.
• Professional certification (i.e. Certified Quality Engineer, Six Sigma Green Belt, Certified Quality Auditor).