Support and/or drive overall implementation, maintenance, and continual improvement of Quality Management Systems (QMS) and Compliance requirements to ensure company and customer compliance (i.e., ISO, Export Controls, REACH, RoHS, Conflict Minerals, etc.) are met and achieved.
Duties and Responsibilities
- Work in conjunction with the Director, Quality Systems and Compliance to ensure Quality System requirements are effectively established and effectively maintained in accordance with all applicable standards and regulations.
- Report to the Director, Quality Systems and Compliance, regularly on the performance of the Quality Management System and any need for improvements.
- Develop metrics and methods of monitoring to ensure QMS and compliance health.
- Generate process flows related to Audits (ISO / Process) as well as regulatory compliance programs (Export, ITAR) or other compliance procedures.
- Maintain current knowledge and expertise of applicable regulations and ISO Standard.
- Research, communicate, and address new statutory, and/or regulatory requirements throughout the organization when/where required.
- Ensure Caring Associates are provided with proper training
- Assist in the development of training materials where needed
- Develop and/or enhance customer process / internal audits to ensure requirements are being met regarding ISO 9001 and/or customer expectations. Duties to include:
- Generating effective and value-added internal product / process audits.
- Capture findings and provide feedback with intent of closing process gaps.
- Ensure timely gap closure
- Track findings/status to highlight overdue actions and ensure owners have visibility.
- Assist in the recruitment and development of internal audit team members (when needed)
- Prioritization of audit schedules (top tier customers, new cells, high touch, etc.) with intent of achieving internal audit ops goals.
- Key contact in ISO 9001 factory audit preparation and execution to include:
- Review previous findings and partner with action item owners to ensure closure
- Assist with ensuring documentation is up to date (CTOS)
- Review for efficiency and value add
- Support coordination of schedules for auditees
- Assistance with prep work, logistics and audit closure.
- Coordinate and/or support closure of corrective actions or opportunities for improvement.
- Drive adherence to Export Compliance (EC) requirements by:
- Analyzing customer shipments and identifying risk
- Evaluating, revising, and maintaining Export Compliance Program (ECP) as needed
- Generating, performing, or participating in EC audits
- Establishing screening protocols and ensuring proper ownership and training takes place
- Establish consistent system for records management, including retention and disposal.
- Implement, update, and maintain compliance documentation
- Support managing Foreign Nationals process (visitors / suppliers)
- Reviewing and updating training materials
- Helping to develop training materials as well as train Caring Associates when/where needed
- Manage the coordination and closure of customer compliance requests related to regulatory standards (i.e., REACH, RoHS, Conflict Minerals, others)
- Evaluate existing processes and develop systematic approaches for long term maintainability
- Act as a key source of knowledge for REACH, RoHS, Conflict Minerals, and other regulatory standards as needed
- Other duties as assigned.
- Bachelor’s Degree – Significant professional experience may be considered in lieu of certain educational requirements.
- Positive attitude, self-motivated, tenacious follow up, and exceptional organization skills.
- Exceptional customer service attitude.
- Experience and knowledge of requirements and maintenance of ISO 9001 Quality Systems.
- Experience in conducting ISO, Process, and/or Internal Audits.
- Experience with REACH, RoHS, and Conflict Minerals including the ability to understand, interoperate and apply applicable regulatory requirements
- Ability to manage both short and longer-term projects
- Strong interpersonal skills; must be capable of effectively establishing professional rapport with internal personnel, various levels of management, and external partners.
- Proactive approach in communicating status of current processes as well as ideas for improvement.
- Effective organizational, communication, presentation, and writing skills.
- Understanding of manufacturing quality management processes and controls.
- ISO 9001:2015 formal auditor training is a plus
- Export Compliance knowledge
- Generally works in an office environment, but may occasionally be required to perform job duties outside of the typical office setting.
- Must have a reliable form of transportation and ability to travel to other company locations.
- Flexibility to work extended hours when needed.
Note: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and/or skills required of all personnel so classified.