MAJOR RESPONSIBILITIES:
· Provide Quality expertise in Product Development, QMS, Design Control activities, Design History Files, CAPA, Risk Management, and CE Technical Files.
· Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications.
· Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
· Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
· Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
· Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
· Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
· Coordinate product testing with internal and external laboratories as required.
· Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.
Education:
· Bachelor’s degree in Engineering, Science, Math or other related technical field.
Role Details:
· Work Schedule: Monday–Friday, 8:00am – 5:00pm
· Hybrid Work Model
o Monday & Friday: Remote
o Tuesday, Wednesday, Thursday: Onsite (no flexibility here) MUST be onsite these 3 days
· Location: Northfield, IL OR Chicago, IL
Candidate Qualifications:
· 2–5 years of Quality Engineering experience
· Medical device or pharmaceutical industry experience required
· Strong working knowledge of 21 CFR Part 820 and/or ISO 13485
· Handson experience with Device History Files (DHF) and CAPA
Experience supporting operations, investigations, and compliance activities in a regulated environment
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