Supplier Quality Engineer
Job Description
Job Title: Supplier Quality Engineer
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Location: New Port Richey FL
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Shift: Standard
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Duration: 7 months+ extension
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Job Purpose
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Develop, establish, and maintain quality engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements. Serve as a Quality representative to promote awareness, visibility, and communication of quality initiatives while supporting departmental, functional, site, divisional, and corporate quality goals and priorities.
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Provide focused quality engineering support across new product development, manufacturing operations, and quality systems.
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Key Responsibilities
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Identify and implement effective process control systems to support product development, qualification, and ongoing manufacturing, ensuring compliance with internal and external requirements.
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Lead the implementation of quality assurance processes, process controls, and Corrective and Preventive Action (CAPA) systems.
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Act as an effective leader and team member in supporting quality disciplines, decisions, and practices.
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Apply systematic problem-solving and root cause analysis methodologies to identify, prioritize, communicate, and resolve quality issues.
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Develop and execute streamlined business systems to effectively identify and resolve quality issues.
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Maintain compliance with applicable quality requirements and integrate quality into all aspects of work.
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Supplier Quality Responsibilities
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Drive exceptional product quality, patient safety, customer satisfaction, regulatory compliance, and optimization of the Cost of Quality.
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Improve supplier quality performance through the implementation of Part Quality Plans (PQP) for assigned suppliers.
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Communicate, clarify, and facilitate supplier PQP submissions, including reviewing and approving PQPs for purchased products.
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Approve supplier selection through robust qualification processes, including supplier audits.
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Ensure supplier compliance with Quality Management System (QMS) and applicable regulatory requirements.
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Ensure Corrective and Preventive Action (CAPA) plans are developed and executed by assigned suppliers in accordance with established CAPA processes.
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Qualifications & Requirements
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Bachelor's degree in an engineering or technical discipline. Candidates with a non-technical degree must have at least 7 years of experience in manufacturing, engineering, or quality assurance.
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Minimum 5 years of experience in manufacturing, engineering design, quality assurance, or regulatory assurance.
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Strong problem-solving, analytical, and root cause analysis skills.
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Ability to lead, influence, and collaborate with cross-functional teams to drive quality improvements and organizational change.
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Desired Qualifications
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ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
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Demonstrated knowledge of Quality Management System (QMS) tools and continuous improvement methodologies.
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Demonstrated supplier quality experience within the medical device industry.