Senior Manager, Quality Position Available In Greater Bridgeport Planning Region, Connecticut

Job Description:

Join Our Team as a Senior Quality Manager! Hey there! Are you aquality guru who loves making sure everything is just right? Do youget a kick out of improving processes and ensuring top-notchstandards? If so, we want you on our team! At Paragon Medical -Bridgeport, a business of Ametek, we’re all about delivering thebest. Our innovative products and services are shaking up theindustry, and we need a Senior Quality Manager to keep us on trackand push us even further. So if you thrive in a dynamic environmentand love the thrill of ensuring top-notch standards, we have theperfect opportunity for you! Paragon Medical, a business of AMETEK,is a trusted partner in medical device manufacturing, offeringend-to-end solutions from concept to final production. Withexpertise across various applications, we deliver high-precisioncomponents and complete products tailored to exceed customerexpectations. As the Sr Quality Manager, you will be responsiblefor operational compliance with Paragon Medical – Bridgeport’s QMS,FDA, and

ISO 13485

requirements and to ensure that all productsmanufactured by the organization meet customer specifications,customer requirements and medical device requirements per

FDA 21CFR 820.

Responsible for multiple domestic and internationalmanufacturing and design sites and leading all quality operationsfunctions. Will work closely with the assigned site leadershipteam(s) in driving day-to-day operations and ensuring compliance tothe site procedures and regulatory requirements, as well as timelyand effective management of Quality Management System and the KeyPerformance Indicators.

Role Responsibilities:

Provides day-to-dayleadership and management that mirrors the adopted mission and corevalues of the company. Management of Paragon Medical’s dailyQuality function supporting operations to include customersatisfaction, complaint management, new product introduction,product transfer, inspection, non-conformance, calibration,inspection methodology, device history records, training,statistical process control, risk management, and guidance ondivision metrics. Develops client relationships to betterunderstand requirements and to provide point of contact to improvecustomer satisfaction. Manages the Quality Leadership at selectedfacilities and associated internal quality functions. Responsiblefor responses and closure of customer non-conformances whichincludes solid, documented and compliant investigation andcorrective actions. Drives process improvement (example:

Statistical Process Control (SPC)) to improve quality performanceand to minimize reliance on inspection. Leads the selection anddevelopment of state-of-the-art quality inspection methods andtechnology to ensure effective and efficient product verificationapplications. Leads and develops the Quality Assurance team thatcomprises of Quality Assurance, Quality Control, AutomatedInspection, Quality Engineering and Supplier Quality. Ensureson-going compliance with FDA’s QSR/GMP requirements and any otherapplicable regional and international regulations. Implements andenforces daily compliance of quality systems that meet the FDA QSRregulations and are certified to ISO Standards. Accomplishes thisin a manner that is complimentary to manufacturing operations.

Prepares for and represents the company with customer andregulatory representatives conducting inspections/audits of MW LifeSciences systems and facilities. Leads Quality Systems ManagementReview of the QSR and provides resources supporting the InternalAudit function. Participates in the internal and external CAPAfunctions. Provides budget inputs and tracks actual costs, takingactions to comply with budgetary and strategic objectives.

Establishes, tracks and reports timely performance metrics. ISOManagement Representative.

Education:

Bachelor’s degree inEngineering or related field required. Certiifed Quality Managerpreferred