Section Manager / Assistant Manager, QA

TECAN CDMO SOLUTIONS PN SDN. BHD.; Simpang Ampat; On-site; MYR 134,000 - 201,000; Full time

Job summary

TECAN CDMO Solutions (M) Sdn. Bhd. is seeking a seasoned Quality Lead to head IQC, FQA, Calibration and DHR teams, ensuring smooth daily operations, MRB clearance and on-time dispositions.

You will monitor incoming/outgoing processes and drive non-conformance closure. You will support the QMS function during CAPA reviews, develop and review QMS procedures, conduct line audits, and represent the organization during customer visits and inspections.

Qualifications

• 4–8 years of experience in Quality management.
• Strong knowledge of QMS and EMS.
• Experience leading IQC, FQA, DHR and MRB processes.
• Capable of driving CAPA and non-conformance closure.

Responsibilities

• Lead IQC, FQA, Calibration and DHR teams on day-to-day activities.
• Monitor the incoming/outgoing process and MRB disposition.
• Drive non-conformances to closure and ensure effectiveness.
• Support the QMS function during CAPA reviews.
• Develop and review QMS procedures, work instructions & forms.
• Conduct line audits to ensure documentation compliance.
• Represent the organization in customer visits and inspections.

Skills

IQC

FQA

DHR

CAPA

QMS

EMS

Data Analysis

Leadership

Education

Bachelor degree

Master degree

Tools

QC Tools

Data Analysis Tools

Job description

Lead IQC, FQA, Calibration and DHR teams on day-to-day activities. Continuous monitoring of the incoming and outgoing process. Manage the clearance of the MRB to ensure no delayed dispositions. Manage and drive non-conformances efficiently.

Supporting the QMS function on the technical portion of the during CAPA review.

Drive improvement on daily operation to ensure efficiency and quality driven.

Lead Incoming Quality Control.

Lead Final Quality Assurance.

Lead DHR Team.

Monitor the incoming part performance and control to ensure no impact on production.

Monitor the outgoing product quality to ensure detection of non-conforming products.

Manage and drive non-conformance closure and effectiveness.

Manage the MRB for both incoming and outgoing materials. Drive to keep value within the company target.

Represent the organization in customer visits, inspection and certification as required

Develop and review QMS Procedure, Work Instruction & Forms

Conduct line audits to ensure compliance with the documentation and requirements.

Ensuring DHR is reviewed and submitted for approval to Quality engineers & customer on timely manner.

Provide input for inspection criteria based on customer feedback, production issue and supplier issues.

Key contributor in setting up the FMEA and process control plan for the product handled.

Contribute on the technical portion of the CRB, CAPA & Non-Conformance meeting.

Ensuring calibration plantwide is monitored and enforced.

Data monitoring and reporting for each section.

Others as per assigned by the reporting manager

Basic Education

Degree

Further Education

Master

Experience

4~8 years experience in Quality

Language Skills

Technical Knowledge and Skills

Strong knowledge of the quality policy and procedures

Knowledgeable in QC tools and Data Analysis

Good QMS & EMS knowledge

Good awareness on legal & best practices for QA

Leadership Competencies ( Decision Making, Problem Solving, Strategic Thinking, Analytical Thinking, Managing Shared Values & Critical Thinking)

Core Competencies (Communication, Teamwork, Innovative, Assertiveness, Responsible, Self-Discipline & Drive Excellence)

About Tecan

Tecan is a global leader in laboratory automation and life sciences, helping customers accelerate healthcare innovation from research to the clinic. With more than 3,300 employees across Europe, North America, and Asia, Tecan offers meaningful careers where innovation, collaboration, and continuous learning drive positive impact on millions of lives worldwide.

About Tecan

Tecan is a global leader in laboratory automation and life sciences, helping customers accelerate healthcare innovation from research to the clinic. With more than 3,300 employees across Europe, North America, and Asia, Tecan offers meaningful careers where innovation, collaboration, and continuous learning drive positive impact on millions of lives worldwide.