Katalyst CRO
Overview
Supplier Quality Assurance Engineer focuses on driving improvement and corrective actions in the quality of components sourced from outside suppliers, and collaborates across supplier engineering, manufacturing/test operations, commercial sourcing, design assurance, and R&D to address supplier-related projects and investigations. Responsibilities
Drives improvement and corrective actions in the quality of components sourced from outside suppliers. Assesses and drives reactive as well as proactive supplier projects/investigations, partnering with Supplier Engineering, Manufacturing/Test operations, Commercial Sourcing, Design Assurance, and R&D. Develops solutions to a variety of complex problems of diverse scope and complexity, where data analysis requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit. Plans and organizes non-routine tasks with approval. Initiates or maintains work schedules and priorities. Plans and organizes project assignments and maintains project schedules. Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approaches to solutions. Interprets, executes, and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives. Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represent a specialized field in larger project teams. Influences middle management on business solutions. Contributes to the completion of specific programs and projects. Recognizes that failure to obtain results or erroneous decisions could result in program delays and resource expenditure. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other quality processes and procedures. Ensures appropriate resources are maintained to assure Quality System compliance and adherence to the Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality Systems. Requirements
BS degree in an Engineering-related field (e.g., Mechanical, Materials, Chemical, Electrical) or a similar technical degree with 2-4 years related experience. Experience in Quality Management Systems, regulatory compliance, and risk management. Experience with problem-solving quality tools, Corrective/Preventive Actions (CAPA), and Technical Documentation. Experience with or lead auditor certification to ISO13485, 9001, TS16949 standards. Ability to communicate cross-functionally with suppliers, team members, and leadership. Highly organized and detail-oriented with the ability to manage multiple projects and priorities. Senioriry level
Associate Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
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Supplier Quality Assurance Engineer focuses on driving improvement and corrective actions in the quality of components sourced from outside suppliers, and collaborates across supplier engineering, manufacturing/test operations, commercial sourcing, design assurance, and R&D to address supplier-related projects and investigations. Responsibilities
Drives improvement and corrective actions in the quality of components sourced from outside suppliers. Assesses and drives reactive as well as proactive supplier projects/investigations, partnering with Supplier Engineering, Manufacturing/Test operations, Commercial Sourcing, Design Assurance, and R&D. Develops solutions to a variety of complex problems of diverse scope and complexity, where data analysis requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit. Plans and organizes non-routine tasks with approval. Initiates or maintains work schedules and priorities. Plans and organizes project assignments and maintains project schedules. Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approaches to solutions. Interprets, executes, and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives. Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represent a specialized field in larger project teams. Influences middle management on business solutions. Contributes to the completion of specific programs and projects. Recognizes that failure to obtain results or erroneous decisions could result in program delays and resource expenditure. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other quality processes and procedures. Ensures appropriate resources are maintained to assure Quality System compliance and adherence to the Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality Systems. Requirements
BS degree in an Engineering-related field (e.g., Mechanical, Materials, Chemical, Electrical) or a similar technical degree with 2-4 years related experience. Experience in Quality Management Systems, regulatory compliance, and risk management. Experience with problem-solving quality tools, Corrective/Preventive Actions (CAPA), and Technical Documentation. Experience with or lead auditor certification to ISO13485, 9001, TS16949 standards. Ability to communicate cross-functionally with suppliers, team members, and leadership. Highly organized and detail-oriented with the ability to manage multiple projects and priorities. Senioriry level
Associate Employment type
Contract Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr