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Quality System Associate

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This job is about ensuring quality in products by handling customer complaints and maintaining important documents. You might like this job because it involves problem-solving and communication, helping to uphold standards in healthcare.

Undisclosed

Port Klang / Pontian, Kuala Lumpur

Job Description

Role Responsibilities:

  • Acknowledge and respond to customer complaints within the defined timelines, utilizing Complaint Investigation Reports (CIR), Corrective and Preventive Actions (CAPA), or other relevant tools.
  • Ensure that the handling of customer complaints complies with international standards, regulatory requirements, and customer agreements.
  • Ensure all quality system documents are properly maintained and updated in compliance with international standards, regulatory requirements, and customer agreements.
  • Manage document revision to maintain the integrity, accuracy, and security of master documents.
  • Monitor and follow up with relevant parties on gap analyses related to new regulatory or standard updates to ensure continued compliance.
  • Assist the Quality Management Representative (QMR) in preparing and conducting management review meetings as required.
  • Review and report to the Group Quality Manager on potential medical device recalls or reporting needs arising from customer complaints or identified non-conformances.
  • Perform any other duties or tasks as assigned by the Head of Department (HOD).

 

Role Requirements:

  • Must possess at least a Bachelor Degree of Science or any related discipline.
  • Good oral and written communication skills in English and Bahasa Malaysia.
  • Basic knowledge in Microsoft Word & Excel.
  • Good communication and analytical skills.

 

Submit your resume to
hr@karex.com.my
We regret that only shortlisted candidates will be notified.
Thank you and have a nice day!


Job Requirements


Company Benefits

Career Growth

We encourage our employees to fully utilise their potential by offering ample training, education and personal development opportunities.

Medical Benefits

Employees gets medical coverage as the enter the company!

Work-Life Balance

Enjoy our work-life balance benefits either with hybrid working or FlexiHours!


Additional Info

Company Activity

Last active - few days ago

Job Specialisation


Company Profile

Karex-logo-image

Karex

From our early years, Karex had to think of many new ways in order to close the competitive gap faced when entering an industry filled with established incumbents. The result is that until today, we fabricate all our own machinery allowing us to rapidly adapt our manufacturing lines to accommodate to the ever-changing customer preferences. Moreover, we have always prioritised remaining at the forefront of new product...