Development Quality Engineer

Donatelle Plastics
501 County Road E2

New Brighton, MN 55112

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Development Quality Engineer

Overview of Responsibilities:

Validation Responsibilities:

·         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)

General Responsibilities:

·         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.

Preferred Qualifications:

Education/Experience:

·         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

Physical Requirements:  

·         Ability to work in a general office setting

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