Quality and Process Improvement Manager

1 week ago


Penang, Malaysia Link Compliance Full time

Link Compliance is seeking a highly skilled Quality and Process Improvement Manager to lead the development and implementation of quality systems and processes.

About the Role:
  • This role will be responsible for managing quality assurance programs, conducting audits, and providing training to ensure compliance with regulatory requirements.
  • The ideal candidate will have a strong background in quality management and experience working in medical device industry.
Responsibilities:
  • Manage quality assurance programs, conducting audits and providing training to ensure compliance with regulatory requirements.
  • Develop and implement quality systems and processes to ensure consistency and efficiency.
  • Collaborate with cross-functional teams, including engineering, quality, and manufacturing to ensure seamless integration.
  • Provide guidance and support to team members, promoting a culture of quality and excellence.
  • Communicate effectively with stakeholders, including customers, engineers, and quality personnel.
Qualifications:
  • Bachelor's degree or higher in Quality Management or related discipline.
  • 5+ years of quality management experience in medical device industry supporting a FDA Class III medical device.
  • Experience working with/in contract manufacturing environment.
  • 'Hands-on' quality acumen and analytical skills
  • Ability to read and understand quality documentation.
  • Process implementation and process validation experience.
  • Experience with quality management software and tools.
  • Solid organizational planning, communication skills, articulate, team player, dependable, able to work in a fast-paced environment with accuracy/efficiency.


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