Summary
Overview
Work History
Education
Skills
Timeline
Generic

Mario Delsignore

New Hyde Park,NY

Summary

Quality, Manufacturing and Engineering professional with over30 years in career in analytical, technical and engineering expertise combined with achievement in cost reduction, quality improvement, project and engineering team management. Effective vendor, customer, and inter-departmental and facility liaison with outstanding troubleshooting, problem-solving, and relationship management skills. Excellent Knowledge of Quality System regulations under FDA21 CFR Part820, OSHA, GMPs, and ISO13485. In my position, I oversee and direct all the Quality of all goods produced. Using process, quality and production improvement methodologies, the Head of Global Quality Management directs the development, planning, implementation and maintenance of methods for new or existing products and technologies through a strong relationship with Engineering and Operations. I also lead and manage the quality group in process improvements, validations, and investigations, in accordance with applicable regulatory requirements and guidelines. Execute day to day activities to ensure attainment of operational goals, tactics, priorities, as well as identify resource needs. Management responsibilities also include coaching staff, and driving business results. My position regularly deals with difficult issues within the department and cross-functionally, and is responsible for making key decisions that will impact both operational and organizational success. I also function as a member of the Company’s Senior Leadership team playing a vital role in the development of Company objectives and the achievement of business goals. Specialties: Six Sigma # New Product Development # Continuous Improvement # Quality Assurance # Statistical Analysis # Methods & Standards Design # R&D/Manufacturing Integration # Training # Validations # Design of Experiments # FMECA # Auditing

Experienced with quality assurance and process improvement initiatives. Utilizes cross-functional leadership to drive compliance and operational efficiency. Track record of implementing quality management systems that enhance product and service standards.

Quality management professional with comprehensive expertise in elevating quality standards and process optimization. Known for fostering collaborative environment focused on achieving consistent results. Skilled in regulatory compliance and team leadership, adaptable to dynamic needs.

Quality management professional equipped to drive and enhance operational excellence. Skilled in quality assurance, process improvement, and regulatory compliance. Strong emphasis on team collaboration and adaptability to changing needs. Known for reliability, strategic thinking, and achieving measurable results.

Focused Quality Controller with [Number] years of experience conducting testing to facilitate quality and condition results. Possesses superior product knowledge to train and educate staff while maintaining optimal product storage and efficiency. Builds and maintains effective working relationships with internal and external customers.

Diligent Quality Manager with [Number] years of experience making sure products and services meet internal and external standards. Skilled in market research, project management, and statistical analysis. Organized and analytical with excellent written and verbal communication skills.

Adaptable Quality Manager with a [Number]-year background in implementing and developing improvement processes through collaboration with cross-functional teams. First-rate computer, analysis and research skills. Specialties include achieving set targets, generating new strategies, and maintaining accurate records. Documented quality control success. Develops specific and measurable goals, improvements, and standards to continuously and consistently improve quality and reduce and eliminate errors. Successfully audits and maintains product accuracy and timely delivery resulting in customer satisfaction. Initiates quality-related SOP training and enforces procedural adherence.

Precise Quality Assurance Manager proficient in all QA operations, policies and procedures. Experience hiring and developing individual team members. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction.

Quality control professional experienced in developing organization's quality strategy, procedures, and processes. Monitor quality performance from supply chain and throughout product development life cycle. Develop and sustain Quality Management System in accordance with ISO 9001 and other applicable standards and business requirements. Manage quality audit program to identify and resolve non-conformities and embed culture of continuous improvement.

Quality Management professional with successful career delivering efficiency and standardization, and maintaining all ISO and QS 9000 and Six Sigma Quality Systems. Drives smooth operation of production and manufacturing lines, coordinate efforts of employees and facilitate communication between management and production departments. Apply creativity in improving manufacturing process to achieve higher productivity and quality of finished goods. Experience in reviewing and interpreting regulatory and programmatic guidance, implementation of corporate compliance, risk management and corrective action programs.


Overview

25
25
years of professional experience

Work History

Head Of Quality Management

Nobel Biocare Procera, LLC
02.2016 - Current
  • Responsible for implementing programs to ensure that all products and services meet company standards and customer requirements
  • - Develop, implement, and maintain the Quality Assurance Management System in accordance with ISO13485: and other applicable quality system requirements
  • # - Process owner of all “quality related processes” from product development, launch of products, manufacturing and product follow up; post-market surveillance
  • # - Develop and monitor the processes and the Quality System together with the Procera (individual production) organization and suppliers
  • # - Host the Manufacturing Quality Review Meetings
  • # - Site management representative
  • # - Train and educate the Procera organization in the Quality Management System and the process approach
  • - Member of the Quality Management Team
  • # - Investigations on Procera quality issues
  • # - Conduct audits to assure that the quality management system is in compliance with the established requirements and to determine its effectiveness
  • # - Guide the operations towards decided quality objectives
  • # - Responsible to make sure the business is in compliance with relevant regulatory requirements
  • # - Responsible to attend and act as a host to any quality assessments by authorities inspectors visiting the site
  • # - Member of the global internal audit team
  • # - Close cooperation with the Global Quality Team (Sweden, United States, and Japan)
  • Led a team of quality assurance professionals, ensuring consistent adherence to company standards and regulatory requirements.
  • Initiated cross-functional collaborations with engineering and manufacturing teams to identify root causes of defects and implement corrective actions.
  • Developed comprehensive training programs for new hires, resulting in increased efficiency and knowledge among staff members.
  • Streamlined quality control processes by integrating automated systems and reducing manual inspection tasks.
  • Managed the resolution of customer complaints, leading investigations to determine cause and implementing corrective actions to prevent recurrence.
  • Conducted regular audits of production processes, identifying areas for improvement and implementing changes to enhance overall product quality.
  • Evaluated vendor performance through routine assessments, recommending adjustments or replacements as necessary to maintain optimal supply chain relationships.
  • Collaborated with suppliers to establish stringent quality criteria for incoming materials, enhancing overall product consistency.
  • Implemented Six Sigma methodologies throughout various departments, resulting in improved operational efficiencies and reduced process variability.
  • Increased customer satisfaction through timely response to inquiries, thorough investigation of issues, and implementation of corrective actions as needed.
  • Enhanced employee engagement in quality initiatives by recognizing individual contributions and promoting a culture of accountability.
  • Championed a culture of continuous improvement by fostering open communication channels between employees at all levels within the organization.
  • Oversaw the maintenance of ISO 9001 certification by ensuring continuous process improvements within the organization.
  • Reduced waste by optimizing manufacturing processes, increasing overall production efficiency while maintaining high-quality output.
  • Coordinated recall efforts when necessary, collaborating with internal stakeholders as well as external partners to ensure effective communication and resolution strategies were employed.
  • Developed and maintained comprehensive documentation of quality processes, ensuring consistent adherence to established procedures across all departments and teams.
  • Ensured compliance with industry regulations by staying up-to-date on changing standards and providing guidance across multiple departments.
  • Improved product quality by implementing rigorous inspection processes and updating standard operating procedures.
  • Served as a primary point of contact for regulatory agencies during inspections and audits, demonstrating the company''s commitment to compliance and continuous improvement.
  • Managed and archived quality documentation and participated in internal and external quality audits.
  • Updated quality control standards, methods, and procedures to meet compliance requirements.
  • Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
  • Coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
  • Increased customer satisfaction through adherence to quality standards and customer requirements.
  • Evaluated quality problems and performed assessments to identify and resolve issues.
  • Mentored and encouraged employees to strive for excellence while fostering professional growth.
  • Wrote and implemented new rework procedures to standardize processes and streamline workflow.
  • Improved quality processes for increased efficiency and effectiveness.
  • Inspected inbound and outbound products for compliance with established industry standards, company policies, and procedures.
  • Established and tracked quality department goals and objectives.
  • Tracked quality issues with external customers, suppliers, and internal plant operations.
  • Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.

Director of Quality

Natech Plastics, Inc.
03.2015 - 02.2016
  • - Development, implementation, maintenance, and communication of our existing ISO9001:2008 certified quality management system
  • Gap analysis and transition to ISO13485:2003
  • - Provide leadership for developing and directing improvement thru both our existing CAPA and internal / external audit systems and thru new initiatives
  • - Continuous improvement champion
  • - Work directly with the engineering staff on process improvements and new manufacturing initiatives to ensure they will meet customer demand and satisfaction
  • - Motivating and inspiring system document ownership at all organizational levels
  • - Management of quality functions thru staff of5 including: customer requirements implementation, inspections, control of records, and audit
  • - Communicate closely with customers regarding all quality related issues with the goal of enhancing satisfaction

Senior Director of Manufacturing and Technical Operations

Chembio Diagnostic Systems, Inc.
11.2013 - 03.2015

Director of Quality Assurance and Engineering

International Technidyne Corporation
01.2007 - 11.2013

Senior Manager of Quality Engineering

Pall Corporation
01.2000 - 01.2007

Education

Six Sigma Black Belt -

American Society of Quality
01.2003

Project Management

American Management Association
01.2000

Mechanical Engineering

Manhattan College
05-1980

Skills

  • ISO13485
  • Quality Systems
  • Six Sigma
  • CAPA management
  • Operational excellence
  • Documentation control
  • Quality management systems
  • Product inspection
  • Preventive actions
  • Corrective actions
  • Change control management
  • Quality metrics monitoring
  • Quality system review
  • Supplier quality management
  • Test method validation
  • Statistical process control
  • GMP auditing
  • Customer complaint handling
  • Problem-solving
  • Continuous improvement
  • Document management
  • Performance monitoring
  • Compliance monitoring
  • Internal auditing
  • Total quality management
  • Operational improvements
  • Operation Monitoring
  • Design of experiments
  • Management consulting
  • External audit support
  • Strong work ethic
  • Teamwork
  • Teamwork and collaboration
  • Time management
  • Problem-solving abilities
  • Excellent communication
  • Critical thinking
  • Organizational skills
  • Team leadership
  • Relationship building
  • Adaptability and flexibility
  • Decision-making

Timeline

Head Of Quality Management

Nobel Biocare Procera, LLC
02.2016 - Current

Director of Quality

Natech Plastics, Inc.
03.2015 - 02.2016

Senior Director of Manufacturing and Technical Operations

Chembio Diagnostic Systems, Inc.
11.2013 - 03.2015

Director of Quality Assurance and Engineering

International Technidyne Corporation
01.2007 - 11.2013

Senior Manager of Quality Engineering

Pall Corporation
01.2000 - 01.2007

Project Management

American Management Association

Six Sigma Black Belt -

American Society of Quality

Mechanical Engineering

Manhattan College
Mario Delsignore