AMETEK ยท 3 hours ago
Senior Quality Engineer
Bridgeport, CT
Full-time
Onsite
Mid, Senior Level
$90K/yr - $115K/yr
3+ years expAMETEK, Inc. is a leading global provider of industrial technology solutions serving diverse markets. The Senior Quality Engineer will be responsible for ensuring customer requirements are met in the manufacturing of surgical instruments and implants, while developing and implementing quality systems and procedures to comply with ISO and FDA standards.
ElectronicsManufacturing
Responsibilities
Assists in the development and implementation of systems and processes that foster continuous improvement for product development and/or manufacturing
Responsible for ensuring cell processes are correctly base-lined & controlled. Known variability is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC
Completes the implementation and performance of gage R&R, process capability studies, design of experiments, and summaries as required to improve quality and to provide required deliverables to customers
Ensures processes released with use of SPC where applicable and/or promote the utilization of SPC
Provides SPC & ongoing monitoring of SPC
Investigates deviations, OOS, complaints, returns, recalls, and field alerts
Supports the Material Review Board (MRB) for internal non-conformances and customer returns
May lead or verify effectiveness of corrective and preventive actions (CAPAs)
May liaise directly with customer representatives
Supervise and train personnel in the inspection of raw materials, in-process and finished goods by using statistical sampling techniques and precision measuring instruments to check conformance to requirements
Verify that all production procedures have been followed and the records such as Device Master Records and Device History Records are maintained per FDA & customer requirements and Paragon Medical requirements
Design inspection/validation steps to be taken by operations at the point of manufacture and integrate these steps into the manufacturing instructions
Responsible to create, implement and improve quality systems and procedures for meeting ISO 13485, FDA and customer quality system requirements
Work in conjunction with Cell Leaders to ensure CNC Machinists are knowledgeable and competent in the use and care of sensitive measuring equipment and related requirements such as calibration, recording of data, expected variability, etc
Provide day-to-day oversight of quality including batch testing, inspection, calibration, environmental monitoring, qualification, document review, etc
Creates and supports ECN's and SCR's (product)
May authorize, initiate and/or approve product and process changes
Supports both internal and external audits of all corporate quality systems and demonstrates compliance through objective evidence
Qualification
Required
Bachelors Degree in Engineering or related field
3-5 years experience with tight tolerance measurement systems in machining applications
Experience in blueprint reading
Knowledge of GD&T
Working knowledge of short-run process control methods
Experience with DOE
Familiarity with ISO standards
Knowledge of FDA quality system regulations
Strong written and verbal communication skills
Excellent customer teaming and interpersonal aptitude
Strong computer skills including excellent Word, Excel, PowerPoint, and Minitab skills
Excellent organizational skills and attention to detail
Demonstrates problem solving skills, applying effective, data-driven, mistake-proofing concepts
Strong project management skills
Excellent follow-up skills
Ability to work with limited supervision
Ability to actively participate in a team-oriented, continuous improvement, manufacturing environment
Company
AMETEK
AMETEK is a manufacturer of electronic instruments and electromechanical devices.
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
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2025-11-11
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2025-11-08
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