Quality Management System Specialist

Carlisle, PA

Employer:

Description

Description

This position of Quality Management System (QMS) Specialist will be responsible for developing, organizing, implementing, and maintaining our Quality Management System in accordance with ISO 9001:2015 standards. Implementation of the ISO 9001 quality management system with the goal of compliance and certification will support the overall Carlisle Quality Management System as well as the Carlisle Operating System (COS) maturity framework. This role will involve collaboration with the manufacturing sites to ensure compliance, monitor processes, and drive continuous improvement initiatives. This role will communicate with various departments to ensure that the Integrated Management System (IMS) is functioning in accordance with ISO 9001, ISO 14001, ISO 50001 and other ISO management systems by developing strong relationships and influencing plant leadership.

Normal hours worked will be 8:00 a.m. to 5:00 p.m., Monday - Friday (40 hours/week). This role involves approximately 20% travel, but this may increase intermittently based on business need.

Duties and Responsibilities:

QMS Development and Implementation:
- Develop and enhance the organization's Quality Management System (QMS) based on ISO 9001 standards and identify gaps that exist with the existing QMS and develop a plan to bridge those gaps.
- Refine existing Deviation, Change Management, Trial Requests, Customer Complaint process, Document Management System, etc. to support a robust QMS that will be executed upon at the manufacturing plants.
- Ensure that QMS documentation is up-to-date and accessible to all relevant personnel.
Compliance Monitoring:
- Develop concise auditing documentation and assessments to facilitate routine auditing to ensure compliance with ISO 9001 standards.
- Identify areas of non-compliance and develop strong corrective action plans.
Training and Awareness:
- Develop a plan to create training curriculum and guidance to employees at all levels to foster ISO 9001 and IMS awareness, understanding and utilization.
- Facilitate training sessions and workshops related to quality management.
Continuous Improvement:
- Drive continuous improvement initiatives to enhance the efficiency and effectiveness of processes within the organization.
- Collect and analyze data to identify opportunities for improvement.
Risk Management:
- Identify and assess potential risks to quality and recommend strategies for risk mitigation.
- Work with relevant stakeholders to address and resolve quality-related issues.
Documentation and Reporting:
- Maintain comprehensive records of QMS activities, audits, and corrective actions.
- Prepare and distribute regular reports on the status of the QMS and its effectiveness.
External Audits and Certifications:
- Prepare for and support gap analysis and external audits to support each plant and central support function as they pursue ISO 9001 compliance or certification.
- Collaborate with external auditors and certification bodies.
Customer Focus:
- Monitor customer feedback and complaints related to quality.
- Implement improvements to meet or exceed customer expectations.
International Surveillance Audits:
- Coordinate with the various International Surveillance Audit bodies to schedule routine audits within specific plants.
- Facilitate the execution of the audits in collaboration with the plant Quality leaders, identifying and documenting any observations or non-conformances that are uncovered.
- Manage the corrective actions related to the identified observation and non-conformances to ensure maintaining of the international certification.
Other duties as assigned

Required Knowledge/Skills/Abilities:

Effective written and verbal communication skills.
Project Management skills.
Interpersonal skills.
Mathematical and analytical skills.
Strong decision making and problem-solving skills.
Familiarity with company products.
Knowledge of ISO 9001 quality management system.
Knowledge of basic quality systems and philosophy.
Knowledge of computer operations.
Knowledge of research and development priorities.
Knowledge of six sigma methodology/TQM/Continuous improvement/SQC.
Knowledge of lean manufacturing methodology.

Education and Experience:

Required:
- Bachelor's degree in Engineering, Statistics, Business or relevant field.
- Five years of Quality Control/Quality Assurance in manufacturing is required.
- Experience in a technical role within the manufacturing industry required.
- Experience in an ISO 9001 Quality Management System environment is required.
Preferred:
- Familiarity with relevant regulatory requirements and standards beyond ISO 9001 is preferred.
- Project management skills preferred.
- Two years of process engineering experience is preferred.

Working Conditions:

Individual will operate primarily in an office setting in Carlisle, PA
Individual will occasionally be in a plant environment where it may be dirty, dusty, and hotter/colder than office settings.

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