Role : Validation Consultant/ Project Quality Engineer
Work Location : Cincinnati, OH
Duration of assignment (in Months) : 12 months
Relevant Experience(in Yrs) : 5-10 Years
Technical /Functional Skills
The Supplier Quality Engineer should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility.
He should also be able to:
• Perform supplier evaluation and qualification
• Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
• Develop validation master plans, process flow diagrams, test cases, or standard operating procedures.
• Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
• Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
• Conduct Designs validation study features, such as sampling, testing, or analytical methodologies.
• Develop project plans for Validation/Qualification projects
• Write master plans relating to any specified projects and conduct meetings to execute the validation plan.
• Direct validation activities, such as protocol creation or testing.
• Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment.
• Adhere to all customer/company and GMP procedures, along with safety regulations within the workplace.
Experience Required
• A minimum of 5 years' experience in a highly regulated industry is required. Medical Device and/or Pharmaceutical industry is preferred.
• Experience in supplier evaluation and qualification
• Strong knowledge of Advanced Product Quality Planning (APQP),
Production Part Approval Process (PPAP), Failure Mode and Effect Analysis (FMEA)
• Lean Manufacturing knowledge
• Understanding supplier manufacturing processes
• Ability to work in a diverse and dynamic environment
• Planning and prioritising activities
• Good communication and interpersonal skills
• Experience in interpreting graphs, charts, engineering diagrams, blueprints, shop orders, equipment guides and other instructions to solve problems.
• Experience writing Functional Requirements, Design Specifications, FAT's, SAT's, IQ's, OQ's, PQ's.
• Experience executing FAT's, SAT's, receipt verification, IQ, OQ, PQ.
• Experience using scientific rules and methods to solve problems.
• Experience in identifying complex problems and developing and evaluating options and implementation of solutions.
• Should have knowledge of Process and Product Validation requirements and techniques.
• Excellent problem solving and decision-making skills will be required. Interpersonal skills that foster conflict resolution as it relates to technical situations will be required.
• Process validation experience is required.
Roles & Responsibilities
• Authoring and approving IQ/OQ/PQ document
• Authoring and approving engineering study
• Authoring and approving test methods
• Supplier evaluation and qualification
• Execute & report all validation activities including analysis (DQ / IQ / OQ / PQ / PPQ / PFMEA)
• Work with Engineering (Design and Manufacturing Engineers) team to define process parameters and criteria to ensure supplier process capability is effective to meet product and process requirements
• Facilitate root cause analysis and corrective actions of supplier quality issues
• Collate and evaluate supplier quality data to identify process improvement opportunities within the supply
• Work with the supplier directly, create correction action plans to address process failures
• Review supplier manufacturing processes, collaborate with suppliers on process improvement and value enhancement opportunities
• Participate in cross-functional teams in the development of new products or changes related to current products in meeting customer requirements
• Support and lead process improvement activities at the supplier place.
• Review and provide solution for rejection and prepare QC and production report.
• Prepares, maintains, or reviews validation and compliance documentation, such as engineering change notices, schematics, or protocols.
• Ensure compliance to the laid down quality system requirements and ISO 13485 standards.
• Studies product characteristics or customer requirements and confer with management to determine validation objectives and standards.
• Directs validation activities, such as protocol creation or testing.
• Prepares validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment.
• Work with other teams/departments to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges
Generic Managerial Skills
Supplier Quality Engineer will assume the role of team leader and organize QA and other departments to achieve the successful introduction of new products, including:
• Handling several projects concurrently
• Meet delivery promise in terms of budget and timescales.
• Work within a multi-discipline team, consisting of the R&D Development Group, Marketing, Quality, Operations, etc.
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