MANAGEMENT
To ensure the suitability, adequacy and effectiveness of the QMS and to ensure we are consistently meeting customer and regulatory requirements.
To ensure the suitability, adequacy and effectiveness of the QMS and to ensure we are consistently meeting customer and regulatory requirements.
QP 5.0
1) RESPONSIBILITY
Chief Executive Officer
Norbert Kozar
Responsibilities:
Establish credibility throughout the organization and with the Board as an effective developer of solutions to business challenges.
Provide leadership and management to ensure that the mission and core values of the Company are put into practice.
Drive the Company to achieve and surpass sales, profitability, cash flow, and business goals and objectives.
Spearhead the development, communication, and implementation of effective growth strategies and processes.
Develop, establishing, and promoting positive strategic relations through direct contact with every client and partner; representing the Company with clients, business partners, investors, and the general public.
Assist as required, in raising additional capital at appropriate valuations to enable the Company to meet sales, growth, and market share objectives.
Chief Operations Officer
Chad Yaw
Responsibilities:
Works with the Executive Team to develop the strategic direction for the company, including the development and implementation plans for operational infrastructure of systems, processes, and personnel to accommodate the rapid growth objectives of the organization.
Collaborates with management and other stakeholders to raise capital and carry out other business-expanding strategies.
Oversees the daily business and administrative operations and drive continual improvement for optimal efficiency.
Works with the Quality department to develop and improve policies and procedures that improve and promote company vision and culture.
Coordinates with the Quality department to maintain quality standards, ensuring quality is designed into the process.
Assists with driving Root Cause analysis, fast closed-loop corrective actions to prevent escapes and resolve deficiencies.
Mentors Leads to have Quality and Safety first, and ensure their employees are trained on any QMS processes and work instructions necessary.
Leads and motivate staff to achieve sales and organizational objectives.
Mentors and inspires employees to key into the vision of management and the company.
Assists with evaluating company performance and recommend strategies to improve results.
Chief Financial Officer
Stephen Dillon
Responsibilities:
Work with the CEO to develop the strategic direction for the company to continue to grow in a more profitable way.
Drives the development of the organization’s plans and programs as a strategic partner.
Drives the company to achieve sales, profitability, cash flow, and business goals/objectives.
Planning, developing, organizing, implementing, directing, and evaluating the organization's fiscal function and performance.
Developing credibility for the finance group by providing timely and accurate analysis of budgets, financial reports, and financial trends in order to assist the CEO/President, the Board, and other senior executives in performing their responsibilities.
Developing a reliable cash flow projection process and reporting mechanism which includes minimum cash threshold to meet operating needs.
Advising from the financial and business perspective on any contracts into which the Company may enter.
Provide day-to-day leadership and management reflecting the core values of the company.
Spearheading the development, communication, and implementation of effective growth strategies and processes
Assisting as required in raising additional capital at appropriate valuations to enable the company to meet sales, growth, and market share objectives.
Represent the company with clients, investors, and business partners.
Executive Vice President
Melissa Kozar
Responsibilities:
Scheduling Responsibilities:
Oversees the production and shipping schedules to ensure product is efficiently moved through the company and meets on-time delivery goals.
Train others on the new Dashboard system functions and work closely with the software developers to continuously improve the system.
Alert customer service representatives (CSRs) to contact the customer when scheduling dates need to change.
Leads the daily production meetings.
Finance Department Supervising Responsibilities:
Accounts Receivable: Manage/communicate collection goals and address concerns.
Lead/monitor closing procedures for month-end and year-end results.
Manages improvement projects to streamline existing finance activities.
Continuously review financial activity for potential gaps and inefficiencies to improve overall performance.
Continuously improve ways for monitoring and communicating financial KPI’s through visible dashboards for management and company.
Analyzing financial reports.
Human Resources Supervising Responsibilities:
Lead human resource department in maintaining a healthy work environment and ensuring sound policies and procedures are in place.
Reviews corporate policy packages: health insurance, workers’ compensation, EPLI, D&O, liability, etc.
Assist with and/or lead employee disciplinary actions.
Assist with and/or lead interviews and recruitment for open positions.
Chief Quality Officer
Daniela Kozar
Responsibilities:
Lead development and implementation of comprehensive quality measurement and improvement programs.
Instruments to develop and implement a vision, strategic plan, measurement infrastructure and continuous improvement program
Analyzes, evaluates, and presents information concerning factors such as business situations, production capabilities, and manufacturing problems
Suggests and debates alternative methods and procedures in solving problems.
Cooperates with other top management personnel in formulating and establishing company policies, operating procedures, and goals.
Establishes product quality documentation system by writing and updating quality assurance procedures.
Conducts management meetings with product assurance program department heads to establish, delineate, and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.
Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
Looks for ways to improve and promote quality throughout the company
Monitors the completion of all Corrective Actions in a timely manor
Lead in any Customer audits and Regulatory audits
Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends
Point of contact for customers and vendors at all times
Responsible for presenting the Quality System to new and potential customers.
Ensure company meets 6S system requirements.
2) RELATED REQUIREMENTS:
ISO 13485
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.5.2 Management Representative
5.5.3 Internal Communication
AS9100
5.1 Leadership and Commitment
5.1.2 Customer Focus
5.2 Policy
3) QUALITY PROCESS OBJECTIVE:
OBJECTIVE:
4) EFFECTIVENESS MEASURE:
Measurable quality objectives are established within the monthly quality meeting report, section quality objectives.
Quality objectives are verified for effectiveness on a monthly basis.
If the quality objectives are not met, management will assign activities to ensure that the quality process will perform within set guidelines.
Sustainability: ≤ 90%
5) ACTIVITIES AND EXPECTATIONS:
ACTIVITIES:
EXPECTATIONS:
6) PROCESS INPUT:
Source of Input (predecessor processes):
Operation (internal)
Customer
Management
Contracting
Inputs (matter, energy, information):
7) PROCESS OUTPUT:
Receivers of Output (subsequent processes):
Customer
Operation (internal)
Quality
Supplier
Management
Output (matter, energy, information):
8) RELATED DOCUMENTS:
9) TRAINING REQUIREMENTS:
Mandatory training (to be completed within the first 30 days of assignment)
10) INTERNAL AUDIT- VALIDATION AND VERIFICATION:
Internal audit performed on: _______
Auditor: _________
Findings: _______
The following elements will be validated and/or verified as part of the scheduled internal auditing process.
Validation:
Quality system validated as part of the internal audit
Verification:
Compliance with all applicable requirements
Corrective actions against this process have been closed and are effective
Training Effectiveness
Status of documented information (have there been any changes or new documents issued and if documents have been changed or added have all applicable employees trained)