
Senior Manufacturing Support Engineer (KL)
- Malaysia
- Permanent
- Full-time
- Provide the first point of contact for Manufacturing & Repair on yield, quality and throughput issues.
- Provide solutions to identified Manufacturing & Repair problems
- Supporting NPI activities and helps ensure a smooth transition into production.
- Analyse and resolve complex Manufacturing, Quality and Compliance issues (e.g., CAPA, non-conformances, audit observations)
- Ensure NCR’s, CAPAs, Concessions and Change Notes are processed in a timely manner.
- Identify process solutions and create plans to coordinate activities and mentoring other engineers and technicians when required to progress plan.
- Ability to analyze the failures & challenges using proven method to identify the root cause and implement solution for yield & quality improvement.
- Liaise and collaborate with other departments (warehouse, supply, procurement, NPI) to resolve manufacturing challenges.
- Review product, process and equipment designs, work instruction and safety to ensure the business needs are met without compromising the quality requirements.
- At least 8 years of experience in preferably in a highly regulated GMP manufacturing environment.
- Minimum Bachelor’s degree in Electrical Engineering, Technical or Manufacturing qualification
- Experience in working within a Quality Management system is highly desirable for this role.
- Experience in working within Production Management system (e.g. Oracle)
- Experience in Design of Experiment (DOE), develop protocols, perform process validations IQ/OQ/PQ is a MUST for this role.
- Experience in designing process flow and production line layouts is a MUST for this position.
- Experience in risk management (risk analysis, DFMEA, PFMEA) is highly desirable for this position.
- Experience in designing process flow and production line layouts.
- Exposure to a highly regulated environment working within a Quality Management Systems (QMS) framework – ISO exposure or good understanding of QMS is a MUST for this role.
- Knowledge in Change Management Process is highly desirable.
- Demonstrate strong Project Management skills especially in process improvement and cost saving projects are an added advantage.
- Proven competencies in problem solving, design, manufacturing / business process development and personal influence
- Good interpersonal skills and written communication in English
- Candidates from Medical Device manufacturing industry will have an added advantage.