Remote Medical Device Process Validation Engineer

Akkodis is seeking a Remote Medical Device Process Validation Engineer for a contract job with a client in Bloomington, IN. The role involves working within the Production Engineering - Process Validation Department to identify process validation needs and generate quality outputs for Design History File documents.

Responsibilities:

• Review of process validations for identification of gaps to internal and external requirements
• Identify process validation needs
• Test Method Validation and Process Validation protocol generation, execution, and report generation per applicable Quality System Procedures
• Meet and/ or beat designated deadlines
• Generate quality outputs for Design History File documents (generation of a PFMEA, etc.)

Requirements:

• Bachelor's Degree in Mechanical, Biomedical or Chemical Engineering
• Requires up to one year of post educational experience in medical device manufacturing
• Demonstrate the understanding of medical device regulations and best practices
• Demonstrate a proficiency in statistical, quality and continuous improvement methods and Tools
• Demonstrate knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971)
• MS Office proficiency. Excellent use of Microsoft Word, Excel. Minitab a plus
• Strong technical understanding of manufacturing, process development, and process validation
• Must work well with others, have good problem solving skills and have excellent communication skills (ability to summarize)
• Experience with Design History Files (DHF) and PFMEA's