Quality Manager

Overview

Element has an opportunity for an experienced Quality Manager in the Plano, TX area. Reporting directly to the Business Unit (BU) Quality Director/BU Quality Manager for Connected Technologies & Mobility with a dotted line to the location General Manager, you are an essential member of the management team and responsible for overall quality performance. This includes but is not limited to the Element Quality Management System (QMS), improving First Time Right/Location KPIs, maintaining, and developing relationships with customers and improving processes. The successful candidate will drive a culture of quality assurance, quality improvement, and have a sound working knowledge of ISO/IEC 17025 requirements.

 

In this role, you will interact with clients, Accreditation Bodies, and customers, and will be responsible for advising operational colleagues of the importance of quality, accuracy, and integrity in the provision of the inspection and testing services we provide.

 

You will be involved in leading quality at a local level and supporting several other locations within the general vicinity, working closely with the BU Quality Director/Manager and location General Managers to ensure that Element quality policies, processes and procedures are effectively implemented.  As a quality leader within Element, you will be capable of driving a culture of quality assurance and quality improvement, working closely with your operational colleagues and the wider Element quality community.

 

Responsibilities

• Maintenance and scope extension of all accreditations (e.g. ISO/IEC 17025), and any other regulatory requirements e.g. FCC, ISED, FDA ASCA)
• Implement and maintain the QMS, ensuring the necessary controls are in place to govern the inspection and testing undertaken
• Effectively manage the day-to-day implementation of the QMS and support colleagues in its implementation
• Prioritize activities to meet the needs of the business, colleagues, and our customers
• Embed and drive a culture of quality assurance and quality improvement in all parts of the laboratory operations
• Ensure the continued fulfillment of customer expectations through the implementation of the QMS, e.g. through effective contact review, reporting and in communication with customers or approval bodies
• Ensure that all accreditations are maintained and extended, as agreed with operational management and the BU Quality
• Director, to service our customer base and retrain our competitive position as a leader in materials testing
• Manage A2LA and other assessments and visits from and other regulatory bodies as required
• Ensure that any findings from assessments are responded to in line with the Element established quality requirements and, in the timeline, and format required by the assessment bodies 
• Establish and implement appropriate QA/QC programs to reduce the cost of poor quality and improve compliance to regulations, standards, company objectives and customer requirements
• Ensure training in the electronic quality management system (eQMS) is effective and that colleagues implement the system across the facility
• Drive and monitor the implementation of eQMS ensuring full usage of the available modules
• Provide quality training to colleagues when onboarding and provide refresher training to existing colleagues
• Implement method audits, system audits, and proficiency testing in line with the established schedule(s) and ensure these are maintained and up to date
• Manage calibration program (where applicable), and ensure the program meets the requirements of the facilities.
• Compile and submit monthly Key Performance Indicators (KPI) such as First Time Right (FTR), customer complaints and non-conformances (NCR/Incident)
• Maintain good working relationships with operational colleagues within the locations and with the wider quality community.
• Manage process for control of goods in a secure facility

Skills / Qualifications

• Four-year technical degree preferred (or equivalent qualification)
• Minimum experience level of 5 years of work experience in an ISO quality environment
• Experience of working in an ISO / IEC 17025 environment is a prerequisite
• Experience with A2LA, ISO 17025, and Quality system rules, regulations, including planning and implementation as applicable to the location
• Experience in preparation/leading 3rd party assessments (A2LA, FCC, ISED, etc.)
• Experience with internal audits (prepare, perform, report out, etc.)
• Familiarity with internal compliance audits related to regulatory (FCC and ISED) preferred
• Effective organizational and time management skills with the ability to prioritize act