Quality Manager

Are you ready to make a meaningful impact on patients’ lives? We are looking for an experienced Quality Manager to join a leading organization in the Medical Device industry, located in Klang Valley with a flexible hybrid working arrangement.

What You’ll Do
As the Quality Manager, you will play a vital role in ensuring the organization maintains the highest standards of safety and integrity. Your key responsibilities include:

• Leading initiatives to identify and implement improvements in Quality Systems, enhancing operational efficiency and user experience.
• Serving as the APAC Supplier Management Lead, offering expert guidance to ensure compliance with Supplier Quality QMS requirements.
• Overseeing supplier quality processes such as selection, qualification, audits, approval, communication, non-conformance management, and collaborating with Operations teams.
• Deliver dashboard analysis, trending insights, and solutions.
• Planning and executing Quality System projects within defined scopes and deliverables.
• Managing training compliance for stakeholders.
• Mentoring junior employees by providing guidance on development plans

Your expertise will contribute directly to innovative technologies that improve patient outcomes globally.

What You’ll Bring
We are seeking a skilled Quality Manager with strong technical knowledge and leadership capabilities to excel in this position. The ideal candidate will possess:

• A Bachelor’s Degree in a relevant field with at least 8 years of professional experience in Quality within a regulated industry (Master’s Degree preferred).
• Demonstrated success in project management along with advanced proficiency in Microsoft Office Suite (including Excel) and Quality systems.
• Comprehensive knowledge of process validation, risk management, ISO 13485, 21 CFR 820/11, FDA inspection protocols, and other regulatory standards.
• Strong documentation skills paired with excellent communication abilities for relationship building and negotiation.
• Fluency in English (additional languages are advantageous).

Experience working in manufacturing environments or handling inspections from regulatory bodies like the FDA would be highly beneficial!

What Sets This Company Apart
This is more than just a job—it’s an opportunity to join a global leader in the Medical Device industry that prioritizes innovation and patient care. Here’s what makes this company stand out:

• A collaborative work culture that encourages creativity and problem-solving at all levels.
• Opportunities for career advancement through tailored training programs and mentorship initiatives.
• Flexible hybrid working arrangements designed to support work-life balance while maximizing productivity.

Join an organization that empowers its employees to make meaningful contributions while advancing their careers!

What’s Next?
Ready to take your career to new heights? Don’t miss out on this incredible opportunity! Apply today by clicking on the link or contact Woo Soon Yee at +603 2303 7005 or email SoonYee.Woo@robertwalters.com.my quoting “Quality Manager.” Thank you!

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C