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/AIn 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)
