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Company

Original Job Post

Argon Medical Devices, Inc. · 3 days ago

Senior Quality Engineer

Athens, TX

Full-time

Onsite

Senior Level

8+ years exp

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Responsibilities

Lead in the completion and maintenance of risk analysis and complaint evaluations.

Lead the investigation, resolution and prevention of product and process nonconformance.

Conduct internal audits as assigned and support customer audits for assigned product lines.

Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.

Lead in the Implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

Lead, coach, and mentor non-exempt and entry level exempt personnel.

Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Design and conduct experiments for process optimization and/or improvement.

Appropriately document experiment plans and results, including protocol writing and reports.

Lead process control and monitoring of CTQ parameters and specifications.

Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing) Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).

Work with design engineering in the completion of product verification and validation.

5-10% travel

Qualification

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FDA/ISO Regulation KnowledgeCQECQA

Required

BS Degree and 8 years as a Quality Engineer required.

Previous experience in FDA/ISO regulated industry required.

Preferred

CQE and CQA preferred.

Company

Argon Medical Devices, Inc.

Argon Medical is a global manufacturer of specialty medical products, headquartered in Plano, TX.

Founded in 2003

Plano, Texas, USA

1,001-5,000 employees

http://www.argonmedical.com/

H1B Sponsorship

Argon Medical Devices, Inc. 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)

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Trends of Total Sponsorships

2023 (5)

2022 (7)

2021 (4)

2020 (1)