AMETEK · 3 hours ago
Quality Manager
Bridgeport, CT
Full-time
Onsite
Senior Level
$140K/yr - $160K/yrAMETEK is a leading global provider of industrial technology solutions, and they are seeking a Sr Quality Manager for Paragon Medical. The role involves ensuring operational compliance with quality management systems, FDA, and ISO 13485 requirements across multiple manufacturing sites while leading quality operations and driving process improvements.
ElectronicsManufacturing
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
Qualification
Required
Bachelor's degree in engineering or related field required
Operational compliance with Paragon Medical – Bridgeport's QMS, FDA, and ISO 13485 requirements
Ensure that all products manufactured by the organization meet customer specifications, customer requirements and medical device requirements per FDA 21 CFR 820
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
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
Preferred
Certified Quality Manager preferred
Company
AMETEK
AMETEK is a manufacturer of electronic instruments and electromechanical devices.
Founded in 1930
10001+ employees
H1B Sponsorship
AMETEK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (7)
2023 (2)
2022 (2)
2021 (6)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2007-01-30Acquired
1978-01-13IPO
Leadership Team
David Zapico
Chairman and Chief Executive Officer
T
Thomas Montgomery
SVP & Corporate Comptroller
Recent News
2025-11-11
PR Newswire
2025-11-11
MarketScreener
2025-11-08
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