QMS Engineer [Medical Device]

Randstad Malaysia; Perak; On-site; MYR 60,000 - 80,000; Full time

Job summary

Randstad Malaysia is seeking a QMS Expert for a global leader in medical device manufacturing located in Perak. This role involves establishing and maintaining Quality Management Systems (QMS) in compliance with strict regulatory standards including ISO 13485 and FDA regulations.

The ideal candidate will have 3-5 years of experience in QA/QMS, a degree in a related field, and preferably proficiency in Mandarin for effective communication. This position offers a dynamic environment with career advancement opportunities.

Qualifications

• 3–5 years of experience in QA, QMS, or Regulatory Compliance.
• Solid understanding of ISO 13485 and medical device regulations.
• Mandarin proficiency is a plus.

Responsibilities

• Establish and improve QMS per ISO 13485, FDA regulations.
• Plan and execute internal audits for compliance.
• Manage lifecycle of all controlled documentation.

Skills

QMS expertise

ISO 13485 knowledge

Regulatory compliance experience

Risk management skills

Mandarin proficiency

Education

Degree in Engineering, Science, or related field

Bachelor Degree

Job description

Our client is a powerhouse global leader in medical device manufacturing, dominating the healthcare innovation space. Driven by a relentless obsession with regulatory perfection, they offer a high‑velocity environment where you don't just follow standards - you set them.

If you are a QMS expert hungry for elite industry exposure and a fast‑tracked path to leadership, this is your next definitive career move.

About the Job

• Establish, maintain, and continuously improve the QMS in strict accordance with ISO 13485, ISO 14971, FDA 21 CFR Part 820/QMSR, MDSAP, and EU MDR requirements.
• Plan and execute internal audits while serving as the primary host and coordinator for customer, certification, and regulatory (MDSAP/FDA) external inspections.
• Drive ISO 14971 risk‑management activities (DFMEA/PFMEA, Control Plans) and evaluate quality/regulatory impacts within the Change Control Board (CCB).
• Participate in and approve IQ/OQ/PQ validation protocols and reports, ensuring all equipment and process revalidations meet compliance benchmarks.
• Manage the lifecycle of all controlled documentation (SOPs, WIs, Technical Files) and partner with HR to deliver QMS and regulatory compliance training across teams.

About the Experience

• Degree in Engineering, Science, or a related field.
• 3–5 years of experience in QA, QMS, or Regulatory Compliance, preferably in medical device manufacturing.
• Solid understanding of ISO 13485 and medical device regulations is required.
• Mandarin proficiency is a strong plus to facilitate smooth communication with key stakeholders.

Education

Bachelor Degree