Qa & Ra Officer/Executive

Responsibilities: Lead and monitor daily QA activities to ensure that all implemented system is maintained
Assist in developing, implementing, reviewing and updating quality management policy, procedures and systems are in accordance to ISO 13485, ISO 9001 & GDPMD
Interpret regulatory rules or rule changes and ensure that they are communicated through corportae policies and procedures
Communicate with regulatory authorities regarding pre-sunbmission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
Write or update standard operating procedures, work instructions, or policies
Determine regulations or procedures related to the management, collection, reuse, recovery or recycling of packaging waste
Creating and Maintenance of Product Technical Files and Company QA Manuals in-line with ISO & GDPMD requirements and Local and International Medical Device Regulations
Registering and Maintaining Medical Devices registrations/certificates for product sales and marketing according to Local and International regulations
To maintain accurate records and initiate reports in order to keep track on quality issue
To ensure QA regulatory compliance and product quality requirements are met at all times
Interact with other departments and/or employees in matters concerning inspection to assure acceptable product is produced
Manage CE files. Compile documentation for CE auditing
React NCR reports. To work closely with QA colleague and other departments in order to assist in preventative action (P.A)
Timely compile of documents for license renewal, registration and update
To handle and taking care of internal and external audit from time to time
Any other tasks assigned from time to time
Requirements:
Candidate must possess at least STPM/Certificate/Diploma in any discipline
At least 3 year(s) of working experince is required in the Medical Manufacturing field
Preferably Excecutives specializing in Quality Control/Assurance or equivalent
Good interpersonal and communication skills
Experience with ISO 13485, ISO 9001 & GDPMD, CE and regularity affairs would be an added advantage
Experience in product testing & validation report writing, and FDA regulations would be favourable
A good command of spoken and written in English, Bahasa Malaysia
Attention to details and being able to follow instructions
Able to work under pressure and with minimum supervision
Able to commence work in short period