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Jobs or company...

Quality Assurance Executive

Salary undisclosed
Checking job availability...
Original
Simplified

JOB DESCRIPTION:

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

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

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.

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:

No

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

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