Quality Assurance Executive

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Quality Assurance Executive

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

Time type: Full time

Posted on: Posted 2 Days Ago

Job requisition id: 31109892

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 from time to time by Line Manager.

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 in local language as well as 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)

About Us

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.