Director of Quality (On-Site)

Lahlouh’s business model is built on solving end to end supply chain problems not simply processing transactional print orders. Lahlouh is a partner that focuses on developing collaborative, comprehensive solutions that endeavor to meet all the communication needs of our clients’ dynamic and evolving marketplaces.

Lahlouh's mission is to provide the highest quality, most cost-effective business communications solutions available.

Core capabilities include:

• Sheet-fed Offset Print                                     • Fulfillment / Distribution Logistics
• Digital Print                                                   • Packaging / CAD Design
• Large Format Print                                         • Marketing Promotions
• Full-service Bindery and Assembly                    • Online Solutions                        
• Mailing

 Position:                    Director of Quality
Reports to:                 President
FLSA Status:              Exempt
Department:              Quality Assurance
Location/Shift:          Monroe, Ohio / 1^st Shift (On-Site)
 
Position summary:
           The Director of Quality is responsible for providing leadership and direction for the development, maintenance, and improvement of processes, procedures, and corresponding controlled documentation and systems that comprise Lahlouh’s Quality Management System. They must establish the desired mindset and behaviors to enable a Quality Culture across the organization that results in a competitive advantage. This role will start as an individual contributor with the intent of growing the department and hiring support positions as required.

Responsibilities and Duties:
            Develop and maintain the effectiveness of Lahlouh’s Quality Management System (QMS) to include but not limited to:

• Compliance Management
  • Manage all compliance related activities and documents required to maintain compliance with ISO 9001:2015, FSC, SOC2, HIPPA and Organic Foods Handler regulatory bodies.
  • Manage all regulatory body audits.
  • Manage all customer audits.
  • Manage company initiatives to acquire new certifications as business needs dictate e.g., FDA, Food Handling, GMP’s, Medical Device, Pharma.

• CAPA – manage the CAPA system.  Educate and assist the teams to drive RC identification and PA implementation.  Track the efforts and results. 
  • Manage customer CAR’s to completion.
  • Provide quality, regulatory guidance and feedback to production managers and other QMS users.
  • Lead the resolution of quality issues related to NCR’s and CAPA’s

• Quality Reporting – manage the quality reporting system.
  • Provide management reporting on NCR’s, Spoilage and Company KPI’s
  • Hold periodic departmental review meetings and work with department heads to identify trends, pareto analysis, track and follow up on action items.
  • Work with the teams to implement data collection and processes to support all customer requested SPC reports.
  • Manage the COC (chain of custody) documentation and reporting.

• Document Control – Manage all ISO and other controlled documents. New document creation, update, and signoff cycle.
  • Create, contribute to and manage companywide policies in the areas of Business Continuity, Pandemic Planning, Disaster Recovery.

• Act as the QMS Point of Contact during all audit, inspections, and inquiries.
• Represent QA on project teams and act as the main Quality point of contact for all QMS topics & initiatives.
• Promote a culture of quality and operational excellence
• Provide cross-functional support to any QMS-related requests or issues; partner in troubleshooting and investigations to ensure closure

• Solid understanding of company QMS systems.  Experience with ISO and FDA compliance.  Foods, Medical Device and Pharma compliance is a big plus.
• Experience with CAPA, non- conformance and Risk Management is required.
• Extensive experience with root cause analysis, statistical techniques (Cause and Effect analysis, Fishbone Diagram, 5 Why, Six Sigma processes)
• Excellent organizational skills. Ability to work independently and as part of the team.
• Strong computer skills particularly with ERP/MRP, MS Office Adobe Acrobat, Minitab.
• Experience establishing infrastructure and leading QMS functions; including QMS IT systems highly desirable.
• Minimum of 10 years in a manufacturing environment. 
• Two years of management experience, managing subordinates.

• A BS in a scientific or technical discipline is required.
• Certifications in Quality Management, LEAN and Six Sigma highly desirable.