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Lead Quality Assurance Engineer

2 months ago

GondrecourtleChâteau, Grand Est, United States Russell Tobin Full time

Russell Tobin is collaborating with a prominent specialty manufacturer to expand their team. This is a permanent/direct hire opportunity with a competitive salary range of $115k-$125k/year.

Position Overview:

The Senior Quality Assurance Engineer is essential in promoting a culture of excellence and ongoing enhancement throughout the organization. This role guarantees that all customer, corporate, and regulatory standards are consistently met or surpassed, while also aligning with the organization’s cost and efficiency objectives. The Senior QA Engineer will assist in the improvement and re-validation of manufacturing and inspection processes to uphold exceptional quality standards.

This position is tasked with employing risk-based, industry-standard scientific and engineering methodologies to identify, document, communicate, prioritize, and resolve quality challenges such as nonconformances, customer grievances, and corrective measures.

Furthermore, the Senior QA Engineer will maintain and revise process risk assessments, quality strategies, and control frameworks. They will provide cross-functional quality assistance to critical areas, including supplier oversight, change management, environmental compliance, and equipment/tooling management (e.g., calibration and preventive maintenance).

Core Responsibilities:

  • Ensure compliance with Quality Management System requirements and regulatory standards across all divisions.
  • Fulfill commitments with precision and meticulousness.
  • Stay informed about medical device regulations (e.g., FDA QSR, ISO 13485, and related standards).

Production-Centric Responsibilities:

  • Serve as the quality representative for the Production Focused Team (PFT), ensuring adherence to customer, corporate, and regulatory standards.
  • Provide on-site quality support to resolve production challenges and implement process controls.
  • Investigate and address customer complaints, nonconformities, and supplier quality concerns.
  • Identify and execute process enhancements to boost productivity and minimize costs.
  • Support changes initiated by customers or the company regarding equipment, manufacturing processes, and product specifications.

Communication and Documentation:

  • Ensure potential nonconformances and product issues are documented in accordance with company protocols.
  • Utilize industry-standard Root Cause Analysis techniques to tackle product and process challenges.
  • Provide expertise in risk-based sampling, data analysis, and present findings clearly in reports and presentations.

Continuous Improvement Initiatives:

  • Lead and support continuous improvement (CI) and Lean initiatives.
  • Conduct risk assessments for process enhancement projects and update documentation as necessary.
  • Offer technical expertise in Quality processes, including supplier management, calibration, and preventive maintenance.

Audit and Compliance Support:

  • Act as a subject matter expert during external audits.
  • Participate in internal and supplier audits as required.
  • Perform other related duties and special projects as assigned.

Qualifications:

  • Bachelor's degree in a scientific, engineering, or technical discipline.
  • 5+ years of experience in medical devices or related fields, with direct involvement in quality engineering.
  • Strong comprehension of statistical techniques, data management, investigation methods, and technical documentation.
  • Six Sigma Green Belt (or higher) is highly preferred.
  • Proficient in Microsoft Office and familiar with ERP and statistical software (e.g., EPICOR, MiniTab).