Senior Supplier Quality Engineer
Core
Ensuring business compliance with Quality Management Systems and regulations for medical device suppliers.
Role type
Senior Supplier Quality Engineer
Builds
World-class medical diagnostic instruments and systems
Domain
Life sciences, diagnostics, and biotechnology
Deliverable
client delivery
Required skills
Supplier selection and qualification, root cause analysis, corrective action planning, audit execution, supplier scorecard management, change notification management, material control plan development, Kaizen event leadership, lean process implementation, regulatory compliance knowledge (21CFR820, ISO14971)
Preferred skills
Certified Quality Engineering certification, experience with 21CFR820, experience with ISO14971
Technologies
None explicitly stated
Responsibilities
Plan and organize routine and non-routine supplier tasks including selections, qualifications, audits, and corrective actions; Develop supplier material control plans for product qualification; Act as primary supplier quality representative for root cause and corrective action analysis; Visit suppliers to resolve product performance concerns; Recommend field actions to the product regulatory committee; Lead Kaizen events to improve processes and eliminate waste
Seniority
Senior, hands-on IC