Technical Support Lead Engineer

Key Responsibilities:

• Provide leadership, training and development, guidance and support to the Technical Support team

• Supervise the servicing and maintenance of all the Division’s products (Medical and Security) to ensure performance of the company’s products is up to customer’s satisfaction

• Ensure prompt response to service/fault calls and after-sales support services in accordance to customer Service Level Agreement (SLA)

• Plan and monitor daily manpower, tools and equipment requirements, and maintenance schedule to ensure timely execution in accordance to SLA and advise end-users of potential problems and follow up on them

• Monitor and check on Integrated Management System (IMS) and Quality Management System (QMS) requirement of maintenance, service and project works and perform routine check on engineers’ progress and performance

• Review work-in-progress status or completion of contracts and submission of reports to customers if required and attend to customers’ complaints

• Coordinate with sales and project team on proper installation, testing and commissioning, maintenance during Defect Liability Period (DLP) and take-over of installed sites post-DLP

• Formulate and document maintenance and service work instructions, safety regulations and procedures for maintenance, service and project works at site installations and ensure all safety measures and proper housekeeping rules are observed at work sites

• Carry out internal audits of Quality Manual and Standard Operating Procedures.

• Identify the non-conformance and compile audit reports.

• Follow up on outstanding corrective and preventive actions till its closure.

• Responsible for reviewing team deliverables and adherence to quality and documentation standards, especially in compliance with ISO13485 requirements.

• Comply with the company’s governance policies at all times.

• Ensure that works activities are carried out in accordance with the Workplace Safety and Health Act and its regulatory requirements.

• Any other ad-hoc duties as assigned by the Reporting Manager.

Control of Document and Records

• As Originator, to be responsible for initiation and revision of documents.
  
  Competence and Training

• Determine competence required of staff and identify training and development needs

• Evaluate training effectiveness by assessing if development needs have been met

Purchasing

• Ensure all purchases fulfil conditions stated in purchasing information.

• Evaluate the performance of suppliers once a year.
  

Receiving, Storage and Delivery

• Provide instructions to Storekeepers of any special handling, storage or delivery requirement to prevent damages to goods.
  

Control of Monitoring and Measuring Equipment

• Ensure that all Monitoring and Measuring Equipment are calibrated or verified, or both, at specified intervals, prior to use, against international or national measurement standards, whichever applicable.
  

Risk Management

• Appoint Risk Assessment (RA) member.

• Performs the risk analysis for medical devices that are imported, stored, deliver, installed, maintenance or serviced by O’Connor’s Singapore.

• Ensure all possible risk are addressed in the RA

• Ensure the risk controls are implemented as stated in the RA

• Update Division Head on the status of the risk control measures to reduce or eliminate the risks identified.

• Review the risk analysis when there is new medical devices are introduced / sold by O’Connor’s Singapore

• Identify appropriate training to be conducted and provided
  

Installation, Maintenance and Servicing

• Review Service Call Review Monthly Report for fault trend analysis every month.

• Raise Non-Conformance (NC) for any fault trend that can lead to user/customer complaint.

• Review checklists if there are changes to the manuals as provided by the Principals.

Control of Non-Conforming Product

• Raise NC for any fault trend that can lead to user/customer complaint.

Corrective and Preventive Actions

• Investigate the cause of the non-conformity and implement the Corrective Action / Preventive Action (CAPA) as appropriate.

• Coordinate and monitor the CAPA.

• Evaluate the CAPA that has been implemented and approve all actions taken.

Regulatory Reporting

• Report any complaints to the Division Head, Management Representative and Central Administration

• Trace and identify the location and quantity of the affected product.

Order Processing

• Verify that customer orders received are in accordance to the quotations submitted and accepted by the customer in terms of product description, pricing and terms and conditions.
  

Competence (Knowledge, Skills and Abilities):

• Understanding and knowledge of the Singapore healthcare and inspection security sectors and their operating environment

• Knowledge on the ISO 13485 Quality Manual and relevant Standard Operating Procedures

·       Skills in trouble shooting technical problems related to the company’s products

• Skills in relating to and servicing the end-users with a win-win mind set

• Skills in negotiation with end-users on non-critical product maintenance requirements

• Skills in preparation of materials and presenting in small group settings (user demo and training, customer presentation)

• Good understanding and knowledge of ISO 13485 standards, Company’s QMS and HAS regulatory requirements

Requirements:

• Strong technical knowledge with and certification on in-house products

• Able to deal with routine tasks easily and perform tasks with some level of complexity.

• Take decisions for own tasks in defined degree of freedom.

• Able to anticipate problems and resolve them within guidelines.

• Works independently within guidelines, defined procedures and direction.

• Attend training on ISE 13485 Standards and Internal Audit Course

Education & Experience:

• Degree or equivalent in Biomedical, Security Technology and other related studies

• Minimum 5 years’ experience with at least 2 years of supervisory experience in related industry

• At least 1 tear of relevant experience in internal audit