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Healthcare
Clinical Quality Manager
Oklahoma City, OK

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Now viewing: Senior Quality Manager - Injection Molding
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Michael Page

Senior Quality Manager - Injection Molding

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Job Description

Take ownership of a high-impact quality function Lead enterprise-level quality initiatives within a highly regulated industry About Our Client Our client is a well-established and rapidly growing advanced manufacturing organisation recognised for its commitment to technical excellence, innovation, and quality. They partner with industry-leading customers and maintain rigorous quality standards while fostering a collaborative culture focused on continuous improvement and employee development. Job Description Lead the development, implementation, and ongoing enhancement of the site's Quality Management System (QMS). Establish and execute quality goals, policies, procedures, and strategic initiatives aligned with business objectives. Provide quality leadership on cross-functional projects, including quality planning, timelines, and risk mitigation strategies. Manage internal audit programmes and drive corrective actions resulting from internal, external, customer, and regulatory audits. Oversee CAPA, complaints handling, non-conformance investigations, and root cause analysis activities. Present quality performance metrics, compliance updates, and improvement recommendations to senior leadership. Conduct Management Reviews and ensure the effectiveness of quality systems and processes. Champion continuous improvement initiatives using tools such as SPC, FMEA, Six Sigma, and Root Cause Analysis. Manage inspection, calibration, metrology, and gage control programmes while identifying opportunities for improvement. Serve as a key customer-facing quality leader, responding to quality concerns and supporting customer audits. Analyse quality data and performance trends to identify process optimisation opportunities. Lead risk management activities and support product and process quality throughout the lifecycle. Support validation activities, capability studies, measurement system analysis (MSA), and first article inspections (FAI). Ensure compliance with relevant regulatory and industry standards. Recruit, mentor, develop, and manage quality personnel while fostering a culture of accountability and continuous improvement. Represent the organisation during customer audits, ISO audits, and regulatory inspections. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. The Successful Applicant Bachelor's degree in Engineering, Quality, Applied Science, Business, or a related technical discipline. Minimum of 5 years' quality management experience or 10+ years of progressive quality assurance/control experience within a manufacturing environment. Proven experience leading Quality Management Systems and quality audit programmes. Strong knowledge of regulated manufacturing environments, ideally within medical devices or similar industries. Working knowledge of quality and regulatory standards including
ISO 13485, ISO 14971, EU
MDR, and FDA quality system regulations. Experience with APQP, control plans, metrology, MSA, FAI, and capability studies. Demonstrated success implementing continuous improvement methodologies, including Six Sigma and structured problem-solving tools. Strong leadership skills with experience developing and managing teams. Excellent communication and stakeholder management abilities. Advanced proficiency with Microsoft Office applications. Professional certifications such as ASQ CMQ/OE, CQE, or CQA are highly desirable What's on Offer Opportunity to shape and influence quality strategy at a senior leadership level. Join a growing organisation committed to quality, innovation, and operational excellence. Work within a highly regulated industry where quality has a direct impact on customer success. Lead cross-functional initiatives that drive meaningful business improvements. Excellent opportunity for long-term career growth, team leadership, and professional development

Benefits

  • Professional Development
  • Dental Insurance