Associate Manager, QC Operations

ResMed; Johor Bahru; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading healthcare company seeks a Quality Control Manager to lead and develop teams across multiple locations, ensuring compliance with quality standards and continuous improvement of processes. The ideal candidate will have a degree in Engineering or Science, at least 5 years of relevant experience in ISO-certified industries, and strong leadership and communication skills. Join us in making the world a healthier place with a diverse and inclusive workplace culture.

Qualifications

• At least 5 years working experience in Quality Management positions.
• Experience in an ISO certified industry, preferably pharmaceuticals or medical devices.
• Familiarity with ISO13485 standards.

Responsibilities

• Lead and develop Quality Control teams across all sites.
• Manage and optimize QC processes ensuring compliance with GMP and ISO standards.
• Act independently ensuring quality conformance and resolving issues timely.
• Develop and deliver training in QC procedures.

Skills

Leadership

Quality Management

Problem-solving

Training and development

Communication skills

Education

Degree in Engineering or Science

Tools

Microsoft

Oracle

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!