Supply Process Engineer
our client is a high growth Biotech /medical device mfg co
Responsible for all existing part specifications, resolving raw material issues, supporting cost savings initiatives, improving efficiency through material and process improvement, reducing material cost, and improving the supplier base through monitoring and measurement. Assures compliance with cGMP, quality, and safety standards within vendor base and department.
Analyzes current raw material specifications to ensure appropriate features and limits are in place to support Company manufacturing processes. Defines appropriate incoming inspection requirements.
Evaluates vendor and Company initiated raw material changes and coordinates appropriate testing and validation as required.
Suggests and supports new methods or materials for continual improvement in the quality or efficiency of a product or process.
Works to reduce costs in all areas of manufacturing.
Creates and revises manufacturing documents, specifications, SOPs, safety instructions, validation protocols and procedures and other technical documents to ensure compliance and safety.
Participates in/leads vendor audit program (some travel may be required).
Monitors vendor performance in the areas of quality, on time delivery, and corrective actions.
Researches solutions to a diverse set of challenges in production and development.
Actively participates in teams as necessary to promote continuous improvement and lean initiatives.
Supervisory Responsibilities This position may have supervisory duties. If applicable, carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities would include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing
complaints and resolving problems.
Education and/or Experience
BS degree in Engineering or other related technical/scientific discipline or equivalent work exp
Experience in a mfg environment preferred w/ experience in quality or supplier engineering pref
Exp with GMP or FDA regulated environment pref
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers.