Work as a subject matter expert on validation of manufacturing processes
Perform validation projects based on customer's engineering specifications
Author and execute validation protocols within team framework
Write validation reports related to transfer of the product from development to manufacturing and revalidation reports related to previously validated processes.
Work with other teams at Donatelle and with customers to ensure validation activities meet internal and external customer's requirements
Responsible for improving standard operating procedures (SOP's) and any other associated documentation required for manufacture of new products and/or process changes
Participate in cross functional teams
Resolve or address customer concerns, supply chain issues, and corrective actions effectively and efficiently
Effectively manage projects so they remain within budget, on time, and meets all the quality requirements of the project
Effectively maintain and communicate project statuses, progress toward key milestones and critical path deliverables
Create master validation plans, characterization sample requests, validation sample requests, inspection requests, BOM/process flow deviations, sampling plan justifications, inspection plans, control plans, supplied data agreements, and certificates of compliance.
Work with product development team to manage execution of validation runs (OQ and PQ) and provide solutions to validation challenges.
Create and revise process failure modes and effects analyses (pFMEAs) and lead cross functional pFMEA working meetings.
Work with Precision Engineer and inspection team to develop inspection methods, fixtures, gauges, quality inspection work instructions, and perform measurement systems analysis (MSA)
Interact with customers, suppliers, and coworkers in a professional manner
Follow safety requirements as outlined in the safety manual
Responsibility to protect Donatelle confidential information and Intellectual Property
To effectively demonstrate sound judgment to protect Donatelle confidential information and Intellectual Property
Support other positions on the engineering teams as needed including Project Engineers and Manufacturing Engineers.
Minimum requirement is BS in engineering or equivalent
ASQ CQE certification preferred
Process Validation Professional Certification preferred
4+ years- of experience as a validation engineer preferred
General knowledge in precision manufacturing
Other Qualifications and Desired Skills:
Knowledge of Current Good Manufacturing Practices (CGMP)/Quality System Regulation (QSR), ISO 13485.
Strong problem solving and troubling shooting abilities
Good communication and human relation skills
Project management skills
Proficient computer skills, including MS Office, Minitab statistical software, Adobe Acrobat
Internal Number: 717
For more than 50 years, Donatelle has helped the medical industry bring their products to market in spec, on-time and on budget. We operate under ISO-9001 and ISO-13485 certified systems and are FDA registered. Our medical device contract manufacturing capabilities include complete engineering services, rapid prototyping, in-house tooling design and fabrication, processing capabilities for the entire range of engineering plastics, micromolding, metal injection molding, insert molding, over-molding, white room and clean room molding and assembly, liquid silicone injection molding, and precision machining for metal and plastic components.