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Manufacturing Quality Director (Medical Device)

Job description

Currently I am looking for an experienced Manufacturing Quality Director for a well known Medical Device company. You will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality throughout the manufacturing operations. You will lead the development and implementation of our Quality Management System, drive continuous improvement initiatives, and oversee all quality-related activities at the site.

Key Responsibilities:

  • Regulatory Compliance: Ensure compliance with relevant regulations and standards, including Pharmaceutical, Medical Device Regulations, and ISO.
  • Quality Management System: Participate in the design, implementation, and maintenance of an effective Quality Management System, advocating for continuous improvement throughout the organization.
  • Product Quality: Ensure products comply with market authorization and GMP requirements, advocating for continuous improvement in manufacturing, distribution, and shelf life.
  • Training and Awareness: Ensure management training on and awareness of quality and compliance requirements and take appropriate disciplinary actions for violations.
  • Quality Monitoring: Monitor the effectiveness of Quality Management Systems through self-inspections, metrics monitoring, and participation in management reviews.
  • People Development: Lead people processes, including recruitment, training, coaching, and performance management, to build effective teams and foster professional development.
  • Budget Management: Manage department budget and establish headcount requirements based on production plans and regulatory requirements.
  • Global Compliance: Ensure compliance of the site with the company's global strategy and business compliance processes.
  • Project Management: Manage projects and activities as assigned, ensuring successful completion within established timelines and objectives.

Minimum Requirements:

  • Bachelor's Degree in Science, Engineering, Life Sciences, or related disciplines.
  • Minimum 10 years of experience in the pharmaceutical industry, with at least 10 years in Quality Assurance.
  • Proven people leader & a qualify professional with a min of 15 years of total experience, having exposure in both QC and QA (Aseptic) operations is a must. Also must have sterile manufacturing expereince.
  • Possesses strategic agility, business acumen, and organizational agility.

If you believe you fit the requirements for the role, please click APPLY NOW. Alternatively, you can email your CV to #LI-NME

Data provided is for recruitment purposes only. Business License Number: 10C5117. EA Registration Number: R1544135 - Regrettably, only shortlisted candidates will be notified.

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