Lead Quality Assurance Engineer

2 weeks ago


Wheeling Illinois, United States Argon Medical Devices Inc Full time

Company Overview::

Argon Medical is a worldwide producer of specialized medical products, with its headquarters located in Plano, Texas. The company provides a comprehensive range of medical devices for fields such as Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology. Argon's brand is synonymous with high-quality products that enhance patient outcomes through percutaneous, image-guided procedures. Our core values reflect our beliefs and guide our operations, serving as a moral compass that shapes our organizational culture.

At Argon Medical, we are a collective of individuals united by a mission and a culture that continues to strengthen each day.

Position Overview::

The Lead Quality Assurance Engineer is tasked with the development and maintenance of quality engineering practices, providing essential support within new product development, manufacturing, or system/service support.

Key Responsibilities::

1. Oversee the completion and upkeep of risk assessments and complaint investigations.

2. Direct the analysis, resolution, and prevention of product and process discrepancies.

3. Conduct internal audits as designated and assist with customer audits for relevant product lines.


4. Identify and implement robust process control systems to ensure the development, qualification, and ongoing production of products that meet or surpass internal and external standards.


5. Spearhead the implementation of quality assurance measures, process controls, and CAPA systems aimed at fulfilling or exceeding internal and external expectations.

6. Mentor and guide non-exempt and entry-level exempt staff.

7. Contribute to the design and execution of efficient business systems that effectively pinpoint and address quality challenges.

8. Employ systematic problem-solving techniques to identify, prioritize, communicate, and resolve quality concerns. Design and execute experiments aimed at process optimization and enhancement.

9. Thoroughly document experimental plans and outcomes, including protocol creation and reporting.

10. Lead the monitoring and control of Critical to Quality (CTQ) parameters and specifications.


11. Facilitate and implement various product and process enhancement methodologies (e.g., Six Sigma and Lean Manufacturing). Actively participate in or lead teams that support quality disciplines, decisions, and practices (e.g., serve as a Core Team Member representing the Quality function).

12. Collaborate with design engineering to finalize product verification and validation.

Qualifications::

BS Degree with a minimum of 8 years of experience as a Quality Engineer is required.

Experience in FDA/ISO regulated environments is essential.

Certifications such as CQE and CQA are preferred.

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