Senior Quality Management System Engineer

Job Summary:
The
Senior Quality Management System (QMS)
Engineer is responsible for the development, implementation, and continuous improvement of the organization's Quality Management System (QMS). The role involves conducting internal audits, managing document control, overseeing the corrective action process, ensuring regulatory compliance, handling customer complaints, and executing initiatives aimed at improving operational efficiency, and reducing wastes. The Senior QMS Engineer will work closely with various departments to promote quality standards and support process improvements that align with business objectives and regulatory requirements.

Primary Duties & Responsibilities

1. Internal Quality Audit:

• Plan, schedule, and conduct internal quality audits to ensure compliance with ISO standards, FAMI QS requirements, company policies, and industry-specific regulations.
• Develop audit plans, checklists, and audit reports to assess the effectiveness of the QMS.
• Identify non-conformities and opportunities for improvement, working with teams to ensure timely corrective actions.
• Track the implementation of corrective actions resulting from audit findings.
• Prepare detailed audit reports and communicate results to management, ensuring the closure of audit findings.
• Train internal auditors and coordinate cross-functional participation in the audit process.

2. Document Control:

• Manage the creation, revision, and approval of QMS documentation, including quality manuals, procedures, work instructions, and forms.
• Maintain the document control system and ensure compliance with document management protocols in line with ISO 9001 or other applicable standards.
• Facilitate document reviews and approvals, ensuring all documentation is current and reflective of operational practices.

3. Corrective Action Process:

• Oversee the 8D Qualityze Corrective Action process to address non-conformities and identify root causes.
• Collaborate with cross-functional teams to ensure timely investigation of quality issues, with a focus on identifying systemic problems.
• Lead root cause analysis using methodologies like 5 Whys, Fishbone diagrams, and Failure Mode and Effects Analysis (FMEA).
• Verify the effectiveness of Corrective Actions, tracking the status of actions and ensuring proper documentation is in place.

4. Regulatory Compliance:

• Ensure that the QMS complies with all relevant regulatory and statutory requirements, including ISO 9001, or other industry-specific standards.
• Keep up-to-date with changes in quality regulations and standards, ensuring timely integration into the QMS.

5. Customer Complaint Management:

• Lead the investigation and resolution of customer complaints, working closely with customer service, production, and engineering teams to ensure timely resolution.
• Maintain a complaint log, ensuring all complaints are tracked, investigated, and closed within the defined timeframes.
• Analyze customer complaint trends and work with relevant departments to drive continuous improvements in product quality and customer satisfaction.

6. Cost of Quality (COQ):

• Analyze and monitor the Cost of Quality (COQ), including prevention costs, appraisal costs, internal failure costs, and external failure costs.
• Collaborate with the finance, quality, and operations teams to track and report COQ metrics, providing insights into trends and improvement opportunities.
• Prepare detailed reports and presentations on COQ findings and propose cost-saving initiatives to senior management.

7. Lean Kaizen Improvement:

• Facilitate Lean Kaizen events to identify and eliminate waste, streamline processes, and improve productivity across departments.
• Ensure that Kaizen improvements are documented, sustained, and periodically reviewed for further optimization.
• Lead cross-functional teams in implementing solutions from Kaizen events, ensuring alignment with overall business goals.

8. Employee Engagement and Continuous Improvement Program:

• Promote employee participation in the EECIP program through training and communication.
• Monitor the effectiveness of the suggestion system and report on the number of suggestions, implementation rates, and resulting improvements.

9. 6S Implementation:

• Lead the deployment and implementation of 6S across the organization to improve workplace organization, safety, and efficiency.
• Develop and deliver 6S training to employees, ensuring that all team members understand and adhere to the principles of 6S.
• Conduct regular 6S audits to assess compliance and identify areas for further improvement.
• Track 6S performance metrics, reporting on progress and ensuring that 6S is sustained as part of the company's culture.

10. Training and Support:

• Provide training and support to staff on quality management systems, internal audits, and continuous improvement practices.
• Serve as a point of contact for all quality-related issues within the organization.

Education & Experience

• Education: Bachelor's degree in Engineering, Quality Management, or a related field.
• Experience: 3-5 years of experience in quality management, internal auditing, or related fields, preferably in manufacturing.
• Certifications: ISO 9001 Lead Auditor, or equivalent certifications.

Skills

• Strong knowledge of ISO standards (e.g., ISO 9001, ISO 14001, ISO and regulatory requirements.
• Knowledge of HACCP and GMP principles.
• Proven experience in internal quality auditing, document control, and Corrective Action processes.
• Strong knowledge of Lean manufacturing principles, Kaizen methodologies, and Six Sigma tools.
• Experience in analyzing the Cost of Quality (COQ) and implementing process improvements to reduce quality-related costs.
• Excellent problem-solving skills and familiarity with root cause analysis techniques.
• Strong organizational skills with attention to detail and a focus on accuracy.
• Effective communication skills, both verbal and written, with the ability to present data and audit findings to cross-functional teams and management.
• Proficiency in QMS software and document control systems.

Working Conditions

• This role is 100% onsite