Lead Quality Assurance Engineer

1 week ago

White Bear Lake, Minnesota, United States RTA US Full time
Job Overview

RTA US is seeking a dedicated and experienced Quality Assurance Engineer to join our dynamic team. This is a permanent position offering a competitive salary in the range of $115,000 to $125,000 annually.

Position Summary:
The Lead Quality Assurance Engineer is crucial in promoting a culture of excellence and ongoing enhancement throughout the organization. This role guarantees that all client, corporate, and regulatory standards are consistently fulfilled or surpassed, while also aligning with the organization's cost-efficiency and productivity objectives. The Lead QA Engineer will assist in the improvement and re-validation of manufacturing and inspection procedures to uphold exceptional quality standards.

This position involves employing risk-based, industry-standard scientific and engineering techniques to identify, document, communicate, prioritize, and resolve quality challenges such as nonconformities, customer grievances, and corrective measures.

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

Key Responsibilities:

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

Production-Focused Duties:

  • 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 nonconformities and product issues are documented according to 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 experience in quality engineering.
  • Strong grasp of statistical methods, data management, investigative techniques, and technical writing.
  • Six Sigma Green Belt (or higher) is highly desirable.
  • Proficient in Microsoft Office and familiar with ERP and statistical software (e.g., EPICOR, MiniTab).

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