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About Kleboe Jardine Ltd
Kleboe Jardine Ltd is a well-established company in the medical device industry, specializing in the production of sterile injectables used in various medical procedures.
The company has a strong presence in the global market, with a reputation for excellence in quality and innovation.
Job Summary
We are seeking a highly skilled and experienced Senior Manufacturing Quality Engineer to join our Quality team. The successful candidate will be responsible for developing and implementing quality metrics, analyzing data, and leading quality improvement projects.
Key Responsibilities
- Quality Metrics and Planning
- Develop and collate quality metrics to ensure compliance with regulatory requirements
- Produce quality plans for existing products and processes
- Data Analysis and Reporting
- Analyze data and trends in performance/variation of the product, process, non-conformance reports, and corrective and preventative actions
- Use statistical methods to identify areas for improvement
- Quality Improvement and Continuous Improvement
- Lead and facilitate quality improvement projects in partnership with Manufacturing and Engineering
- Collaborate with cross-functional teams to identify and implement process improvements
- Risk Management and Compliance
- Facilitate risk management activities, including FMEAs
- Ensure compliance with regulatory requirements and industry standards
- Technical Documentation and Communication
- Write and review technical documents, including standard operating procedures and work instructions
- Communicate quality-related information to stakeholders, including Production and Engineering teams
- Internal Audit and Quality Assurance
- Participate in internal audits to ensure compliance with quality standards
- Conduct process, product, and workplace audits to identify areas for improvement
Requirements
- Experience in the medical device industry, with a strong understanding of regulatory requirements
- Excellent analytical and problem-solving skills, with the ability to interpret data and make informed decisions
- Strong communication and interpersonal skills, with the ability to work effectively with cross-functional teams
- Proficient in the use of quality tools and techniques, including statistical methods and FMEAs
- Demonstrated ability to write and review technical documents
- Proven ability to work independently and as part of a team, with a strong commitment to quality and excellence
