Quality Assurance Executive

Job description

JOB DESCRIPTION:

PRIMARY OBJECTIVE:
Responsible for Quality Management system and to be 100% compliance with Corporate, Divisional and local regulations.

EDUCATION/QUALIFICATIONS/EXPERIENCE:

·  Minimum of Bachelor’s degree in Science. Equivalent education/work experience will be considered.
·  Working experience in a Commercial Quality environment in Medical Device or Pharmaceutical organization will be of advantage.
·  Knowledge of local Medical Device regulations
·  Computer proficiency in Word, Excel and PowerPoint.
·  Strong interpersonal skills, with the ability to build and maintain relationships.
·  Effective time management - well organized, able to set and reset priorities
·  Strong oral and written communication skills.
·  Detail and deadline oriented.
·  Conversant local language as well both written and spoken English.
·  Ability to work and flourish in a fast-paced multi-tasked environment
·  Demonstrates a highly positive attitude concerning risk, change and unexpected challenges.
·  Tendency to be friendly, cooperative, agreeable. To be a team person. Promotes the benefits of teamwork and cooperation. Is usually willing to share resources and information.
·  Good in English Communication Skills

EXPERIENCE REQUIRED:

·  Working experience in a Commercial Quality environment in Medical Device or Pharmaceutical organization will be of advantage.

CORE JOB RESPONSIBILITIES:

·  Support in developing, implementing, assuring and monitoring the Quality and Regulatory Compliance strategies of the company
·  Supports Complaint Handling/ post market surveillance and follow up actions
·  Assignment of QMS training to employees on quality related documents and policies
·  Preparation of monthly KPI data
·  Provide inputs for Management Review Meeting including updates on adequacy and effectiveness of Quality Management system.
·  Manages the document control for QMS procedures and quality records
·  Support and prepare affiliate for Internal & External Quality & Compliance Audits.
·  Prepare and help to obtain and maintain the GDPMD Certification and/or applicable Quality related certification in the region.
·  Support external, internal and supplier audit and the follow-up remediation plan.
·  Support investigation, defining root-cause and implementation of Corrective Action and Preventive Actions in a timely manner.
·  Execution of Product Stop Shipment, Field Safety Corrective Actions as per instructions from Regional or Divisional QA.
·  Interacts on a periodic frequency with Commercial, Regulatory Affairs, Supply Chain, Technical Service, Education and other functions on all quality related matters.
·  Manage the change control process to meet amendment to local regulatory compliance requirements.
OTHER FUNCTIONS AND RESPONSIBILITIES:
·  Perform various administrative functions as required.
·  Any other activities as assigned time to time by Line Manage

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

AVD Vascular

        

LOCATION:

Malaysia > Selangor : Imazium, No. 8, Jalan SS 21/37

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)