Job Listing

JOB DESCRIPTION

Summary 

Proven expertise in ISO 9001, ISO 13485, and FDA 21 CFR Part 820 compliance and implementation, with a strong background in the MedTech industry

Responsible for the implementation of the corporate quality policy and system on materials, process, and finished goods to meet the determined quality level to reduce quality loss.

ü  Incoming Material Control

ü  Qualification

ü  Customer Complaint

ü  Compliance visit (QMS, EMS, and OSH Management Systems)

ü  Quality System (QMS, EMS, and OSH Management Systems/ Standards)

ü  eSPC

ü  MSA

ü  Calibration

Specific Duties And Responsibilities

·  Develops and manages all aspects of quality control activities to ensure that the production of finished goods conforms to quality specifications and standards.

·  Coordinates with Operation, NPI Engineering, and SCM team in failure analysis, product defect research, and all aspects of quality improvement.

·  Coordinates customer complaints on product and corrective actions so that it does not recur or occur elsewhere.

·  Participates in the strategic development of the company through QMS, EMS, and OSH Management Systems/ Standards & other projects such as Six Sigma approach, FMEA, etc.

·  Appointed as Local Quality Management Representative in ensuring effective Quality Management System and Quality Assurance programs, including: -

o  Ensuring that the quality management system conforms to the QMS, EMS, and OSH Management Systems/ Standards requirements.

o  Ensuring that the processes are delivering their intended outputs;

o  Reporting on the performance of the quality management system and on opportunities for improvement, in particular to top management;

o  Ensuring the promotion of customer focus throughout the organization;

o  Ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

·  Initiates problem-solving teams, building linkages to assure a smooth implementation of the quality improvement program.

·  Educates the workforce on quality concepts and practices.

·  Advises on quality issues and initiates internal audit as and when required.

·  Coordinates with external organizations for assistance, guidance, training, audit, and Certification of the quality system.

·  Coordinates outsourcing activities to ensure the parts meet requirements.

·  Directs and motivates subordinates in all aspects of their work.

·  Performs other duties as assigned.