Senior Quality Engineer | Medical Devices | Bangi

Your new company:
A leading Malaysian firm in pharmaceuticals and healthcare, prioritizes quality and innovation. It distributes a diverse range of products, ensuring compliance and safety. Engaged in R&D collaborations, it addresses healthcare needs and supports community health initiatives. They are currently looking for a Senior Quality Engineer to be based in Bangi.

You will be responsible to:

• Participate and support in the assigned new products development and to ensure the quality aspect and requirements including customer requirements are addressed, established and documented.
• Ensure all incoming parts quality, in-process and outgoing inspected products meets the company’s internally established specification and customer’s specification before its release for distribution or use.
• Instruct and train technician and inspector including new inspector on all quality specification and criteria and to ensure that the identified non-conforming products are quarantine to prevent its unintended release or use until the deficiencies are totally overcome.
• Ensure all QA/ QC related forms, work instructions, documents, formats and version utilized are kept updated versus customer specifications, reflected and captured in the Document Controller’s document master list and its associated master copy (electronic and/or hardcopy)
• Perform investigation, monitoring, recording and reviewing all the records from QA/QC internal reject, customer claims (CA/PA), customer complaints and follow-up on the due date of report.
• Establish validation strategy and approach to ensure cost effective validation process being developed through risk management, and maintain the validated state of the equipment, system and process through change control and validation.
• Develop and execute validation / qualification protocol/ plan and register the validation activities in the Validation Master Plan.
• Prepare product, process customer's feedback based Quality Action Plan.
• Ensure all QA/QC records and maintain filing to ensure identification, traceability and retrievability.
• Co-ordinate, monitor, follow-up and update customer returned disposition, in-house recall parts and sorting activities with person in-charge.

You are required to have:

• Diploma or Degree in Science or equivalent.
• Minimum 2 years’ experience in QA/QC with basic 7 QC tools and statistical tools.
• Required skill (s): MS Office and perform data analysis with statistical tools.
• Basic knowledge in ISO 13485:2016.

What you need to do now:
Click Apply now to apply for this role or forward your updated CV to kinyip.chew@jac-recruitment.com
Due to high volume of applications, please note that only short-listed candidates will be contacted. Thank you!
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