Quality Engineer

1 week ago

Minnetonka, United States Element Materials Technology Full time

Overview

Element has an opportunity for a Quality Engineer in Minnetonka. Reporting to the Quality Manager in Cincinnati, you are an essential member of the quality assurance team and influence the overall quality performance. This includes the Element quality management system (QMS), client approvals, improving First Time Right, maintaining and developing relationships with customers and improving processes. The successful candidate will have a sound working knowledge of quality management system requirements.

In this role, you will have interaction with Medical Device clients, Accreditation Bodies, and regulatory divisions and will advise 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 will work closely with the Quality Manager to ensure that Element quality policies, processes and procedures are effectively implemented in Minnetonka. As a quality professional 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.

In this role you will have the opportunity for future career advancement and growth within Element's quality organization.

Responsibilities

  • Maintenance and scope extension of all accreditations (e.g. ISO/IEC 17025), customer approvals and any other regulatory requirements.

  • 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.

  • 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.

  • Ensure that all accreditations are maintained and extended, as agreed with operational management and the Quality Manager, to service our customer base and retain our competitive position as a leader in materials testing.

  • Manage A2LA and customer assessments, 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 dictated by the assessment bodies.

  • 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 in Minnetonka.

  • 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 up to date.

  • Maintain good working relationships with operational colleagues within Minnetonka with the wider quality community.

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