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QA Specialist

Subang Jaya, MY

Ref. number:  2598

Are you looking for a career that matters?

 

If the answer is yes, you think just like us. We are a world-leading medical solutions company, designing and supplying medical solutions to enhance performance in healthcare – from the hospital to the home.

We’re looking for people who want to improve outcomes for healthcare professionals and their patients.

 

Working condition: Part Time – Temporary Employment (Fixed 6 months contract)

 

The Quality Assurance Specialist is responsible for assisting with the operation of the Quality Management System processes and associated programs as needed to achieve and maintain compliance with local, state, and federal regulations.

 

The Quality Assurance Specialist will be accountable for the following activities:

  • Management of the QMS in Malaysia and Singapore; review and implement QMS set-up for India and Thailand (connect to Singapore or eq, not stand alone, not required).
  • Liaise with Global Product complaints team, RA, QA and Health Authorities regarding product complaints, adverse events reporting and field safety corrective actions in all SSEA countries
  • Product Complaints Initiator in all SSEA countries, responsible for registering product complaints in Master Control and monitoring the progress until closure. Push investigators if delays to informing our customers
  • Beneficial if the person can conduct quality audits at distributors and at warehouse vendors
  • Conduct internal audits as required within all SSEA
  • Ensure control of growth markets in terms of Distributor agreements with new and current distributors in all SSEA – quality and regulatory compliance, incl control of any relabelling.

 

The best fit candidate:

  • Knowledge of medical device regulations in ASEAN and India preferred
  • Beneficial if Bachelor's degree in a science based subject or other appropriate curriculum.
  • At least three years of work experiences of Quality preferably from the medical device, pharmaceutical or food industry
  • Quality system auditor/lead auditor
  • Fluent in written and spoken English.
  • Strong analytical skills.
  • Strong communication, planning and negotiation skills.
  • Ability to work as a team player.
  • Ability to work independently, plan and prioritize.
  • Ability to be flexible/adapt as daily schedule may change rapidly.

www.molnlycke.com/careers

 

About Mölnlycke

Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home.

 

We specialise in:

 

  • Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves
  • Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients
  • Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®

 

Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.