Russell Tobin is working with a leading specialty manufacturer in the White Bear Lake area to add to their growing team! This is a permanent/direct hire position with a base salary in the $115k-$125k/year range.
Summary:
The Senior Quality Engineer plays a pivotal role in fostering a culture of quality and continuous improvement across the organization. This position ensures that all customer, company, and regulatory requirements are consistently met or exceeded, while also aligning with the company’s cost and productivity goals. The Senior QE will support the enhancement and re-qualification of manufacturing and inspection processes to maintain high standards of quality.
This role is responsible for utilizing risk-based, industry-standard scientific and engineering methods to identify, document, communicate, prioritize, and resolve quality issues such as nonconformances, customer complaints, and corrective actions.
Additionally, the Senior QE will maintain and update process risk assessments, quality plans, and control plans. They will provide cross-functional quality support to key areas, including supplier management, change management, environmental control, and equipment/tooling control (e.g., calibration and preventive maintenance).
Key Responsibilities:
- Ensure adherence to Quality Management System requirements and regulatory standards across all departments.
- Meet commitments with accuracy and attention to detail.
- Stay current with medical device regulations (e.g., FDA QSR, ISO 13485, ISO 14971) and related standards.
Production-Focused Responsibilities:
- Act as the quality representative for the Production Focused Team (PFT), ensuring compliance with customer, company, and regulatory requirements.
- Provide on-the-floor quality support to address production issues and implement process controls.
- Investigate and resolve customer complaints, nonconformities, and supplier quality issues.
- Identify and implement process improvements to enhance productivity and reduce costs.
- Support customer or company-initiated changes to equipment, manufacturing processes, and product specifications.
Communication and Documentation:
- Ensure potential nonconformances and product issues are documented according to company procedures.
- Use industry-standard Root Cause Analysis methods to address product and process issues.
- Provide expertise in risk-based sampling, data analysis, and present findings clearly in presentations and reports.
Continuous Improvement:
- Lead and support continuous improvement (CI) and Lean initiatives.
- Conduct risk assessments for process improvement projects and update documentation as needed.
- Provide 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 needed.
- Perform other related duties and special projects as assigned.
Qualifications:
- Bachelor’s degree in science, engineering, or a technical field.
- 5+ years of experience in medical devices or related industries, with direct experience in quality engineering.
- Strong understanding of statistical techniques, data management, investigation methods, 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).
