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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 skilled workforce. This is a permanent/direct hire opportunity with a competitive salary range of $115k-$125k per year.

Position Overview:

The Senior Quality Assurance Engineer is essential in cultivating a quality-centric culture and promoting continuous improvement 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 financial and productivity objectives. The Senior QA Engineer will facilitate the enhancement and re-validation of manufacturing and inspection protocols to uphold superior quality benchmarks.

This position involves 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.

Moreover, 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).

Key Responsibilities:

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

Production-Oriented Responsibilities:

  • Serve as the quality representative for the Production Focused Team (PFT), ensuring adherence to customer, corporate, and regulatory requirements.
  • 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 modifications initiated by customers or the company regarding equipment, manufacturing processes, and product specifications.

Communication and Documentation:

  • Ensure that 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:

  • Lead and support continuous improvement (CI) and Lean initiatives.
  • Conduct risk assessments for process improvement 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 additional 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 sectors, with direct involvement in quality engineering.
  • Strong grasp of statistical methods, data management, investigative techniques, and technical writing.
  • Six Sigma Green Belt (or higher) is highly preferred.
  • Proficient in Microsoft Office and familiar with ERP and statistical software (e.g., EPICOR, MiniTab).