Quality Engineering Manager

Paragon Medical, a business of AMETEK, is a trusted partner in medical device manufacturing, offering end-to-end solutions from concept to final production. With expertise across various applications, we deliver high-precision components and complete products tailored to exceed customer expectations.

As the Sr Quality Manager, you will be responsible for operational compliance with Paragon Medical – Bridgeport’s QMS, FDA, and ISO 13485 requirements and to ensure that all products manufactured by the organization meet customer specifications, customer requirements and medical device requirements per FDA 21 CFR 820. Responsible for multiple domestic and international manufacturing and design sites and leading all quality operations functions. Will work closely with the assigned site leadership team(s) in driving day-to-day operations and ensuring compliance to the site procedures and regulatory requirements, as well as timely and effective management of Quality Management System and the Key Performance Indicators.

Role Responsibilities :

• Provides day-to-day leadership and management that mirrors the adopted mission and core values of the company.
• Management of Paragon Medical's daily Quality function supporting operations to include customer satisfaction, complaint management, new product introduction, product transfer, inspection, non-conformance, calibration, inspection methodology, device history records, training, statistical process control, risk management, and guidance on division metrics.
• Develop client relationships to better understand requirements and to provide point of contact to improve customer satisfaction.
• Manages the Quality Leadership at selected facilities and associated internal quality functions.
• Responsible for responses and closure of customer non-conformances which includes solid, documented and compliant investigation and corrective actions.
• Drives process improvement (example : Statistical Process Control (SPC)) to improve quality performance and to minimize reliance on inspection.
• Leads the selection and development of state-of-the-art quality inspection methods and technology to ensure effective and efficient product verification applications.
• Leads and develops the Quality Assurance team that comprises of Quality Assurance, Quality Control, Automated Inspection, Quality Engineering and Supplier Quality.
• Ensures on-going compliance with FDA's QSR / GMP requirements and any other applicable regional and international regulations.
• Implements and enforces daily compliance of quality systems that meet the FDA QSR regulations and are certified to ISO Standards. Accomplishes this in a manner that is complimentary to manufacturing operations.
• Prepares for and represents the company with customer and regulatory representatives conducting inspections / audits of MW Life Sciences systems and facilities.
• Leads Quality Systems Management Review of the QSR and provides resources supporting the Internal Audit function.
• Participates in internal and external CAPA functions.
• Provides budget input and tracks actual costs, taking actions to comply with budgetary and strategic objectives. Establishes, tracks and reports timely performance metrics.
• ISO Management Representative.

Education :