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quality manager

2 weeks ago

Seri Kembangan, Selangor, Malaysia SMARTSURGN SDN BHD Full time 60,000 - 120,000 per year

WWW.SMARTSURGN.COM

QUALITY MANAGER

Job Description

  • Manage and report the status of ECOs, DCOs, NCRs, and CAPAs to management. Drives closure of quality activities to maintain the effectiveness of the QMS.
  • Initiate and collaborate with product support teams, engineering, and others on product and process quality issues, as well as proposed changes that may affect product quality.
  • Develop and apply the manufacturing quality toolset to improve process and product quality, including NCR, SCAR, SRB, MRB, PFMEA, IQ, OQ, PQ, GR&R/ measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk/PpK, Cp, SPC, incoming inspection plans, inspection methods, DOE, process data analysis, and DMAIC/PSP.
  • Authorize product shipment, including any hold due to quality, regulatory, or any compliance issue.

Regulatory Compliance: Ensure compliance with FDA regulations, ISO 13485, and other relevant standards.

Process Improvement: Identify areas of improvement for quality deployment and implement a continuous improvement initiative to enhance product quality.

Audit Management: Conduct or drive the internal audits to ensure compliance with the quality management system. Coordinate and manage external audits, such as implementing continuous improvement initiatives to enhance product quality.

  • Participates in audits and inspections.
  • Conduct tests and assessments on products to identify quality issues.
  • Train staff on SSN quality processes as needed.
  • Support staff knowledge and practice of quality and regulatory guidelines as needed.
  • Support quality assurance directives to ensure the quality integrity of manufactured finished goods.

Requirements

  • Bachelor's degree in engineering, Biomedical/Bioengineering, Life Sciences, Chemistry or related discipline.
  • Strong experience and capability in developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry with stringent quality regulations.
  • Certified as an Auditor / Lead Auditor.
  • Experience with QA measuring and testing equipment.
  • 5 to 10 years' experience in highly regulated quality industries.
  • ISO13485, 21 CFR 820.
  • Working knowledge of quality system requirements.
  • Ability to communicate across functional groups to drive completion.
  • Leadership skills and ability to positively influence others.
  • Strong interpersonal and collaboration skills with Engineering, Operations, and Upper Management.

Job Types: Full-time, Permanent

Pay: RM8, RM12,000.00 per month

Benefits:

  • Maternity leave
  • Opportunities for promotion
  • Parental leave
  • Professional development

Work Location: In person