Quality Engineer

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.
• <10% travel requirement

Skills / Qualifications

• Bachelor’s degree (or equivalent qualification) in a scientific discipline.
• Experience of working in an ISO / IEC 17025 environment is a preferred.
• Medical device experience is preferred.
• Candidate must have proficiency in computer applications (Word, Excel, PowerPoint).
• Effective organizational and time management skills with the ability prioritize activities.
• Excellent communication skills.
• Experience in participating in quality investigations, undertaking root cause analysis, developing corrective action plans, and ensuring the effectiveness of actions undertaken.
• Requirement to keep up to date with changes in the quality landscape and maintain personal professional development.
• Ability to identify quality and technical problems and work with colleagues to determine effective and sustainable solutions.
• Ability to collaborate with colleagues and work effectively as part of a team

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Company Overview

Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today’.

When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.

While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.

Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.

Diversity Statement

At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) 

“If you need an accommodation filling out an application, or applying to a job,  please email Recruitment@element.com”