Save Job Back to Search Job Description Summary Similar JobsOpportunity to work with cutting-edge technology not found anywhere elseStrong long-term incentives via development plans & career growth opportunitiesAbout Our ClientMy client is an innovative medical device manufacturer that develops cutting-edge imaging technology that helps health care professionals diagnose and manage diseases more effectively. Their advanced products are used globally, offering a chance to be part of a team that's revolutionizing how this particular medical care is monitored and treated.Job DescriptionDevelop, implement, and maintain the organization's QMS in compliance with ISO 13485 and FDA regulations.Ensure adherence to all relevant regulatory requirements and standards, preparing for and managing audits and inspections.Lead initiatives to enhance product quality and operational efficiency using methodologies such as Six Sigma and Lean.Supervise and mentor the quality assurance team, fostering a culture of continuous improvement and accountability.Monitor and evaluate supplier performance, ensuring that incoming materials meet quality standards.Address customer quality concerns proactively and ensure that products meet or exceed customer expectations.Maintain accurate quality documentation and prepare reports on quality metrics, identifying trends and areas for improvement.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 ApplicantBachelor's degree in Engineering, Quality Assurance, or a related technical/scientific field.Minimum of 5 years in quality management within regulated manufacturing environments.At least 2 years in a leadership or supervisory capacity.Proficiency with FDA Quality System Regulation (QSR) and ISO 13485 standards.Experience with internal and external audits, including CAPA processes and non-conformance management.Familiarity with Lean, Six Sigma, or other continuous improvement methodologies.Ability to implement and monitor quality metrics and KPIs.Competence in using Microsoft Office Suite and quality management software.Experience with data analysis tools and project management applications.Strong leadership and team management abilities.What's on OfferCompetitive base salary and bonus potentialStrong long-term incentives via development plans and career growth opportunitiesCompetitive employee benefitsStrong focus on employee developmentWork with cutting edge technologyTeam-building events, holiday parties, and food trucksContactTaylor RankinQuote job refJN-042025-6724579Job summarySectorEngineering & ManufacturingSub SectorQuality, TechnicalIndustryIndustrial / ManufacturingLocationHudsonContract TypePermanentConsultant nameTaylor RankinJob ReferenceJN-042025-6724579
