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Associate Manager, QC Operations

Associate Manager, QC Operations

ResMedJohor Bahru, Johor, Malaysia
4 days ago
Job description

Let’s talk about Responsibilities :

Strategic Leadership & Team Management

  • Lead and develop QC teams across all sites, review and support team members’ development, identify training and provide opportunities to broaden experience; provide leadership, mentoring and guidance.
  • Foster a culture of collaboration, safety, and continuous improvement within the QC function.

Process & Compliance Management

  • Manage and optimize QC processes for incoming, production and global QC support, ensuring adherence to GMP, ISO, and company quality standards.
  • Responsible for the coordination of incoming, in-process and finished goods inspections, resolving quality issues using sound problem‑solving techniques.
  • Ensure maintenance, filing and archiving of all records associated with the inspection process and tasks are performed timely.
  • Provide leadership and support to calibration team to ensure compliance and maintenance of the Calibration Management System.
  • Operational Excellence

  • Act with independence when making decisions to ensure conformity of product and adherence to quality procedures.
  • Ensure nonconforming products are appropriately managed and NC’s in Production are investigated timely with appropriate evaluation and disposition.
  • Develop and deliver training in QC procedures and product specifications, ensuring staff awareness of new and revised documents.
  • Improve existing Quality Control processes and procedures related to in-process inspection and final inspection and provide monthly reports and tracking and trending data against KPIs incorporating SPC.
  • Subject matter expert for Quality Control operations in transformation initiatives, collaborating with global teams to ensure process alignment and consistency.
  • Stakeholder Engagement

  • Subject matter expert for Quality Control operations in transformation initiatives, collaborating with global teams to ensure process alignment and consistency.
  • Health, Safety & Environment

  • Subject matter expert for Quality Control operations in transformation initiatives, collaborating with global teams to ensure process alignment and consistency.
  • Let’s talk about Qualifications and Experience

  • Builds positive working relationships across the business to ensure that QA is recognized as integral to business success and growth.
  • Develops procedures, processes, metrics and systems to manage and monitor quality compliance.
  • Continuous Improvement to identifies and addresses barriers.
  • Analyses non-conformance data and determines root / cause / corrective actions.
  • Capability of controlling and completing multiple issues with a clear sense of priority.
  • Self-directing and self-motivated with sound leadership and negotiating skills.
  • Excellent written and oral communication skills and the ability to pay attention to detail.
  • Computer literate in Microsoft, Oracle and other relevant software.
  • Required

  • Degree in Engineering or Science discipline with ISO standards training.
  • At least 5 years’ working experience in Quality Management positions in an ISO certified industry (pharmaceutical, medical devices, or equivalent highly regulated industries).
  • Preferred

  • ISO13485 Internal Auditor or Lead Auditor training.
  • Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

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    Operation Manager • Johor Bahru, Johor, Malaysia

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