Coordinate with R&D and Production departments to ensure product specifications accurately reflect the actual product formulation and manufacturing process.
Maintain proper records and ensure all documents are updated and controlled.
Coordinate and arrange production processes according to production schedules and customer requirements....
Performs and documents initial reportability decisions on complaints in accordance with regulations (US FDA) and international regulations (MEDDEV Vigilance, Health Canada, and others as applicable) and company procedures; Elevate complaints that require additional review for regulatory reporting.
Verify that the correct number of complaints have been opened to address all of the issues identified in the complaint description. If required, generate additional complaint records to document all of the issues listed in the complaint description.
Ensure that all complaints requiring customer responses are properly addressed, as assigned; drafts and documents the response in the complaint file....
Conduct routine verification on switchboard according to procedure and standard (IEC 61439-1 and IEC 61439-2)
Perform programming and commissioning for various LV components such as Breaker, Power Monitoring Device, Protection Relay and Communication Device based on ‘user manual’ or work instruction provided.
Perform complete test on the switchboard such as dielectric test, insulation test, primary and secondary injection test, and functional test...
Ensure risk of non-compliance and related business risks are mitigated
Provide quality / technical leadership through mentoring/coaching
Ensure compliance to ResMed QMS; strong knowledge, application of and compliance to FDA Quality System Regulations, GMP, and applicable ISO / regulatory standards...
Apply approval or rejection labels to raw materials and finished goods.
Involved in management of non-conforming products and release of conforming finished goods.
Support roles consist of work in a: clerical, administrative or specialized support tasks in an office or field setting, specialized technical tasks or skilled craft work, and unskilled or semi-skilled operational tasks...
Ability to interpret technical drawings, specifications, and industry standards, and to align production processes with customer and regulatory requirements.
Demonstrated leadership skills, including team management, cross-functional collaboration, and training or mentoring of staff on quality topics.
Strong analytical and problem-solving abilities, with attention to detail and a structured approach to resolving quality issues....