[vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none" gradient_type="default" shape_type=""][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][nectar_icon_list color="default" direction="horizontal" columns="1" icon_size="medium" icon_style="no-border"][nectar_icon_list_item icon_type="icon" icon_family="iconsmind" text_full_html="simple" text_color="#000000" title="List Item" id="1748918720316-7" header="Job Type / Job Level" text="Full-time / Junior Executive" icon_iconsmind="iconsmind-Clock" tab_id="1748918720316-5"][/nectar_icon_list_item][nectar_icon_list_item icon_type="icon" icon_family="iconsmind" text_full_html="simple" text_color="#000000" title="List Item" id="1748918720337-2" header="Job Location" text="Port Klang, Selangor, Malaysia" icon_iconsmind="iconsmind-Location-2" tab_id="1748918720338-7"][/nectar_icon_list_item][nectar_icon_list_item icon_type="icon" icon_family="iconsmind" text_full_html="simple" text_color="#000000" title="List Item" id="1748918720377-1" header="Salary Offered" text="MYR 3,000 - MYR 4,500 (Monthly)" icon_iconsmind="iconsmind-Money" tab_id="1748918720378-0"][/nectar_icon_list_item][/nectar_icon_list][vc_column_text css="" text_direction="default"]
Functions:
- To manage the regulatory compliance function of the company, which include medical device registration, post market surveillance, clinical evaluation.
- To ensure compliance with regulatory requirements from countries / regions such as the EU (MDR), US (FDA), Malaysia (MDA) and so on.
- To develop and maintain Technical Documentation for each medical device category.
- To participate in developing and maintaining Standard Operating Procedures, Work Instructions and Specifications that comply with the relevant regulatory and customer requirements.
- To keep abreast of the regulatory changes and its implications, keeping management apprised at all times.
Profile:
- Degree / diploma in medical, engineering, science or regulatory field
- A minimum of 2 years' experience in regulatory affairs in the medical device industry
- Practical experience in dealing with regulatory bodies (Malaysia MDA or foreign authorized representative such as the EU)
- Good organization skills and proactive in ensuring regulatory requirement are met.
- Good communication skills to maintain communication with external and internal stakeholders.
- Good written skills in English.
- Auditing experience in ISO 13485 or GDPMD will be and added advantage.
Perks & Benefits
- Regular team activities
- Medical insurance
- Personal development opportunities
- Paid training and development
Job Location
LOT 7, LENGKUNGAN HISHAMUDDIN , KAWASAN PERUSAHAAN SELAT KLANG UTARA, 42000 PORT KLANG, SELANGOR[/vc_column_text][/vc_column][/vc_row][vc_row type="in_container" full_screen_row_position="middle" column_margin="default" column_direction="default" column_direction_tablet="default" column_direction_phone="default" scene_position="center" text_color="dark" text_align="left" row_border_radius="none" row_border_radius_applies="bg" overflow="visible" disable_element="yes" overlay_strength="0.3" gradient_direction="left_to_right" shape_divider_position="bottom" bg_image_animation="none" gradient_type="default" shape_type=""][vc_column column_padding="no-extra-padding" column_padding_tablet="inherit" column_padding_phone="inherit" column_padding_position="all" column_element_direction_desktop="default" column_element_spacing="default" desktop_text_alignment="default" tablet_text_alignment="default" phone_text_alignment="default" background_color_opacity="1" background_hover_color_opacity="1" column_backdrop_filter="none" column_shadow="none" column_border_radius="none" column_link_target="_self" column_position="default" gradient_direction="left_to_right" overlay_strength="0.3" width="1/1" tablet_width_inherit="default" animation_type="default" bg_image_animation="none" border_type="simple" column_border_width="none" column_border_style="solid"][vc_column_text]
Job Description:-
The Quality Assurance Executive report to RAQA Manager and herewith responsible for the following functions:
1) To prepare and carry out introduction and training programs for new QA Personnel.
2) Day to day supervision of QA Supervisor, Leaders and Auditors.
3) To ensure that QA Personnel are updated on the latest product standards and changes.
4) To check and ensure that QA Personnel adhere to the relevant QA procedures, which include sampling procedures, etc.
5) Collation of QA data forms and check for proper and accurate recording of QA data.
6) To notify the RAQA Manager and relevant department / section head of any adverse trends in QA matters.
7) Monitor and maintain the non-conforming product control as to ensure proper segregation and identification and only accepted product are released.
8) To ensure the conformance with relevant standards and best practices, which include ISO 9001, ISO 13485, FDA QSR, etc.
9) To be hands on in developing / preparing /maintaining Quality Manual, Standard Operating Procedures, Work Instructions, Specifications, Technical File, Safety data sheet, etc.
10) To participate in routine quality system meetings, such as Management Review, CAPA, Risk Assessment, Safety Meeting etc.
11) To be responsible in preparing Company & Employees for internal and external quality audits.
12) To conduct quantitative assessment and analysis of data in order to make recommendations for changes in process or QC to eliminate the problem.
13) To participate in Continual Improvement Program.
14) To carry out any associated QA function - when necessary, as directed by the RAQA Manager.
16) Conduct investigation and solving customer complaint due to non-conformance and to ensure customer satisfaction.
Job Type : Full-Time
Basic pay : RM3000-RM4000
Benefits : Health Insurance
Working : Mon – Friday (8.00AM-5.00PM) Sat (Alternate) (8.00AM-1.00PM)[/vc_column_text][/vc_column][/vc_row]