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Regulatory Compliance Engineer

1 week ago

Butterworth, Penang, Malaysia Haemonetics Software Solutions Full time
Job Description
The Quality System Engineer will be responsible for managing all quality-related functions, including conducting internal or external audits to ensure compliance with company quality system requirements. Additionally, this role will involve generating trending reports and presenting them at business unit meetings. The successful candidate will have strong analytical and problem-solving skills, as well as excellent communication and presentation skills.
About Haemonetics
We are a leading provider of medical devices that advance the safety, quality, and availability of the world's blood supply. Our commitment to innovation and excellence drives us to attract and retain the best talent in the industry.
Key Responsibilities
  • Audit planning: Conduct internal or external audits as assigned to ensure compliance to company quality system requirements.
  • Report generation: Generates daily, weekly, or monthly trending reports; seeks to improve reporting processes to ensure unified approach and procedures.
  • KPI tracking: Manages the process to gather and communicate quality systems Key Performance Indicators across the organization.

Requirements
  • Degree requirement: Degree in Engineering or Science discipline or equivalent.
  • Work experience: Minimum 3 years working experience in manufacturing environment.
  • Required skills: Knowledge in problem solving, root cause and statistical analysis.