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About The Company
Owen Mumford Ltd is a leading global healthcare organization dedicated to developing innovative medical devices and solutions that improve patient care and enhance clinical outcomes. With a rich history spanning over 70 years, the company specializes in designing and manufacturing high-quality devices for a variety of medical applications, including diabetes management, immunology, and medication delivery. Owen Mumford is committed to maintaining the highest standards of quality, safety, and innovation, ensuring that healthcare professionals and patients worldwide have access to reliable and effective products. The company fosters a collaborative and inclusive work environment that encourages continuous learning, professional growth, and the pursuit of excellence.
About The Role
We are seeking a highly motivated and detail-oriented individual to join Owen Mumford Ltd as a Quality Assurance Specialist. In this role, you will be responsible for ensuring that our products meet stringent quality standards and regulatory requirements. You will work closely with cross-functional teams including R&D, manufacturing, and regulatory affairs to implement and maintain quality management systems, conduct audits, and facilitate continuous improvement initiatives. The ideal candidate will possess a strong understanding of quality assurance processes within the medical device industry and demonstrate a proactive approach to problem-solving. This position offers an excellent opportunity to contribute to a global organization that is committed to advancing healthcare through innovative solutions.
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Qualifications
The successful candidate will possess a Bachelor's degree in Engineering, Life Sciences, or a related field. A minimum of 3-5 years of experience in quality assurance within the medical device or pharmaceutical industry is preferred. Familiarity with ISO 13485, FDA regulations, and other relevant standards is essential. Strong analytical skills, attention to detail, and the ability to interpret technical documentation are critical for success in this role. Excellent communication and interpersonal skills are required to collaborate effectively with internal teams and external partners. Certification in quality management systems (such as CQE or Lead Auditor) would be advantageous.
Responsibilities
- Develop, implement, and maintain quality assurance policies, procedures, and documentation in compliance with regulatory standards.
- Conduct internal and external audits to ensure adherence to quality systems and identify areas for improvement.
- Review and approve validation protocols, technical reports, and product documentation to ensure compliance and accuracy.
- Collaborate with R&D and manufacturing teams to address quality issues and implement corrective and preventive actions (CAPA).
- Monitor and analyze quality metrics and key performance indicators to identify trends and drive continuous improvement initiatives.
- Participate in risk management activities and support the implementation of risk mitigation strategies.
- Provide training and guidance to staff on quality standards, procedures, and regulatory requirements.
- Maintain up-to-date knowledge of industry regulations and standards to ensure ongoing compliance.
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Benefits
Owen Mumford Ltd offers a comprehensive benefits package designed to support the well-being and professional development of our employees. This includes competitive salary packages, health insurance, pension schemes, and paid time off. Employees have access to ongoing training and development programs, fostering continuous learning and career growth. The company promotes a healthy work-life balance through flexible working arrangements and wellness initiatives. Additionally, employees are encouraged to participate in various corporate social responsibility activities, contributing positively to the community and environment.
Equal Opportunity
Owen Mumford Ltd is an equal opportunity employer. We are committed to creating an inclusive environment where all employees and applicants are treated fairly and with respect. We do not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, disability, or any other protected characteristic. We believe that diversity enhances our ability to innovate and serve our customers effectively, and we are dedicated to fostering a workplace culture that values and promotes equality and inclusion.
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