- Manage and maintain the company's Quality Management System (QMS) in accordance with ISO 9001:2015 standards.
- Develop, implement, and continually improve quality policies, procedures, and processes to meet customer requirements and enhance overall product quality.
- Conduct regular internal audits to assess the effectiveness of the QMS and identify areas for improvement.
- Coordinate external audits and certifications to ensure compliance with ISO 9001:2015 standards.
- Monitor key performance indicators (KPIs) to track the performance of the QMS and drive data-driven decision-making.
- Establish and enforce quality assurance and control measures throughout the product lifecycle, from design and development to manufacturing and distribution.
- Collaborate with cross-functional teams to identify and address quality issues, non-conformities, and customer complaints in a timely manner.
- Implement corrective and preventive actions (CAPAs) to address root causes of quality issues and prevent recurrence.
- Conduct supplier quality assessments and work closely with vendors to ensure the quality of incoming materials and components.
- Champion a culture of quality excellence and continuous improvement throughout the organization.
- Provide training and guidance to employees on quality management principles, procedures, and best practices.
- Foster a sense of ownership and accountability for quality among all employees, empowering them to contribute to the company's quality objectives.
- Keep abreast of industry trends, regulatory requirements, and best practices in quality management, and incorporate relevant updates into the QMS as needed.
- Manage a quality systems and inspection team of up to 5 employees, including quality engineer(s) and inspector(s).
- Bachelor's degree in Engineering, Quality Management, Business Administration, or related field required; Master's degree preferred.
- Minimum of 5 years of experience in quality management roles, with a strong background in implementing and maintaining QMS certified to ISO 9001:2015 standards.
- Proven experience leading successful quality initiatives, process improvements, and problem-solving efforts.
- Certified Quality Manager (CQM) or Certified Quality Engineer (CQE) designation preferred.
- Certified Lead Auditor for ISO 9001:2015 and ISO 45001:2018 preferred.
- Excellent analytical, organizational, and communication skills.
- Ability to work effectively in a fast-paced, dynamic environment and collaborate with cross-functional teams.
- Strong leadership skills with the ability to motivate and inspire others to achieve quality objectives.
- Ability to travel up to 10%.
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Quality System Manager - Oak Ridge, United States - Mirion
Description
We are seeking an experienced Quality Management professional to join our team as a Quality Systems Manager. In this role, you will be responsible for overseeing our Quality Management System (QMS) and ensuring compliance with ISO 9001:2015 and other applicable product and process standards. The ideal candidate will possess strong leadership skills, a deep understanding of quality management principles, and a proven track record of driving continuous improvement initiatives.
RESPONSIBILITIES - Quality Management System (QMS) Oversight
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 c)
