Quality Engineer

Overview:

This role demands collaboration across engineering, operations, and product development teams to implement robust quality solutions, troubleshoot issues, and elevate our quality standards in alignment with company objectives. This position offers an exciting opportunity to play a crucial role in refining our Richmond QMS, driving compliance, and enhancing the quality of our products and processes.

Responsibilities:

QMS Correction & Improvement:

• Evaluate, update, and maintain the QMS to ensure compliance with ISO, FDA, and other relevant regulatory standards.
• Conduct gap analysis to identify deficiencies in the current QMS, implementing corrective and preventive actions as needed.
• Develop, revise, and manage SOPs, work instructions, and quality policies to align with industry regulations and best practices.

Process Quality Engineering:

• Lead root cause analysis and problem-solving efforts for quality issues, implementing effective corrective actions to improve product consistency.
• Guide process validation, equipment qualification, and improvements to manufacturing methods.
• Drive continuous improvement initiatives, focusing on reducing process variability, enhancing throughput, and achieving high-quality outcomes.

Compliance & Regulatory Support:

• Ensure that all quality documentation and processes are up to date and compliant with ISO, FDA, and other regulatory standards.
• Support internal and external audits, preparing documentation and leading corrective actions to address audit findings.
• Maintain adherence to GMP standards, ensuring regulatory compliance across all QMS activities.

Supplier Quality Management:

• Audit suppliers to ensure compliance with quality standards, identifying areas for improvement and managing supplier qualification processes.
• Review and approve in-process and final product specifications to establish and maintain stringent quality control measures.
• Collaborate with suppliers on quality improvement initiatives to enhance component quality and reduce defects.

Cross-Functional Project Leadership:

• Lead or contribute to quality projects, such as implementing Lean, Six Sigma, and DMAIC initiatives, to drive continuous improvement across functions.
• Collaborate with Product Development, Operations, and Engineering teams to support new product development and process improvement projects.
• Provide training and mentorship to team members on QMS standards and quality control methodologies, ensuring consistent adherence across departments.

Qualifications:

• Education: Bachelor’s degree in Engineering, Quality Management, or a related technical field required.
• Experience: Minimum of 3-5 years in Quality Engineering, Process Improvement, or Quality Management Systems.
• Certifications: ISO 9001 Lead Auditor, Six Sigma Green/Black Belt, or related certifications preferred.

Skills:

• Proficient in QMS principles, process validation, and root cause analysis techniques.
• Strong analytical skills with experience in Lean, Six Sigma, Kaizen, or similar continuous improvement methodologies.
• Ability to lead cross-functional teams and influence quality improvements.
• Excellent verbal and written communication skills, with the ability to train and support staff on quality standards.

Key Competencies:

• Detail-Oriented: High level of attention to detail to detect and address quality issues proactively.
• Problem-Solving: Skilled in identifying root causes and implementing corrective actions to improve processes.
• Project Management: Capable of managing multiple projects and ensuring timely completion of quality initiatives.
• Leadership: Demonstrated ability to influence others and drive quality improvements across departments.

More About Filtration Group

We are committed to maintaining an entrepreneurial culture built on a foundation of trust and in which our leaders exhibit a strong bias for action.

Filtration Group has over 10,000 employees who are united in their Mission to make the world safer, healthier and more productive.