- Play a Change Coordinator role to coordinate the change communications between internal and external parties according to the change control process
- Responsible to assure that manufacturing processes comply with the product specification and regulatory government agencies requirements. Provide mechanisms for controlling the total quality and establish ways of evaluating the quality of our products. Participate on internal, interfacility and vendors/suppliers quality audits to determine the extent of compliance and effectiveness of operations, to documented policies, procedures, specifications, FDA and ISO requirements.
- Play a Change Coordinator role to coordinate the change communications between internal and external parties according to the change control process. This includes interactions with change initiators/process owners/Quality/Regulatory and external partner.
- Create change notification and obtain change assessment and approval from external partner/coordinate with cross-functional team for changes initiated by external partner. This includes reviewing labeling, product/manufacturing process changes and change documentation.
- Review and approve Engineering Change Orders as Change Coordinator representative on behalf of external partner in the system.
- Lead and execute change control processes and systems for improvement.
- Assure the process and product change control process complies with Quality Systems Regulations and ISO standards.
- Play a change coordinator role for the process and product change control process
- To lead and / or to participate in development, training, qualification and validation activities for product or technology transfers.
- Revises proposals for new product specifications or current specification modifications established by design documentation.
- Monitors and improves goals and metrics established for company and area of responsibility.
- Ensures compliance with company policies, programs, procedures, regarding to government and regulatory agencies regulations (e.g. ISO, FDA, OSHA). Ensure timely response to audit findings.
- Works and implements special projects as assigned by Direct Supervisor.
- Minimum 3 years’ experience in Engineering related to manufacturing of small electro/mechanical devices preferably in a quality assurance or test related capacity.
- Ability to organise, plan and implement
- Pleasant disposition, good communication and interpersonal skills
- Meticulous, Independent, able to multi-task and follow-through with minimum supervision
- Proficient in MS Applications
- Able to work under pressure and meet deadline
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