SUMMARY- The Quality Manager is responsible for leading the quality organization in the entity of Malaysia and supporting harmonization efforts with Singapore entity. As Management representative, the Quality Manager is responsible for effective implementation of the Quality Management System and compliance with applicable regulatory requirements, particularly those related to medical devices. Relies on extensive experience and judgement to plan and accomplish goals. This position will lead and direct the work of others.
Facilitate Management Reviews.
- Lead cross- functional team in the development and implementation of effective quality solution in new product introduction and production. Ensure process compliance on development and manufacturing programs.
Ensure process improvement activities remain in compliance with FDA/ ISO regulations/ Standards/ guidelines and customer requirements.- Lead the internal audit function and hosts external quality audits.
Analyze production performance to drive attainment of quality objectives.
- Ensure manufacturing process validation activities are completed in a timely manner and in compliance with medical device standards.
Lead problem- solving efforts, including customer complaint investigation and analysis to identify and resolve sporadic and chronic quality issue to ensure production to safe and effective products.- Provide oversight on implementation of quality improvement projects such as QCC or Kaizen.
Manage a section of quality staff, activities include interviewing and selecting personnel, assigning of work, managing of performance, training and development, administrating of salary and benefits, and mentoring and coaching of individuals.
- Ad- hoc duties when assigned.
Possess a Degree in Engineering or Science. Master's degree in engineering, Science or MBA is an advantage.
- At least 12 years of relevant experience in Quality Engineering and/ or Management. Having 3 to 5 years experience in applying medical device standards and regulations.
Experienced in Customer Focused Quality and/ or Business Process Improvement.- Conversant with lean manufacturing, process FMEA and quality concepts including Six Sigma, SPC and 5S. Other relevant experiences include product life cycle, technical leadership, cultural awareness and sensitivity, presentation and communication skills, working in global environments and finance.
Excellence communication skills and good inter-personal skills to interact with and lead team members, customers, and vendors. Strong team working, project
- Management and analytical problem- solving skills.
Work with minimal supervision, having latitude to achieve critical quality objectives within the constraints of established business practices and core values of the firm.- Proficiency in ISO 9000, ISO 14000, ISO 13485 & ISO 14971 with solid experience in medical devices manufacturing. Experience in regulatory compliance such as FDA part
21 CFR820 is an advantage.
- Knowledge of ERP system e.g.: SAP, IFS, etc.
Job Type: Full-time
Pay: RM8,
- 00 - RM15,000.00 per month
Schedule:
* Monday to Friday
