Assistant Quality Assurance Manager

Straits Orthopaedics (Mfg) Sdn Bhd; Batu Kawan; On-site; MYR 55,000 - 95,000; Full time

Job summary

Straits Orthopaedics (Mfg) Sdn Bhd in Batu Kawan, Malaysia, seeks an Assistant Quality Assurance Manager to oversee supplier quality, audits, and CAPA processes. You will collaborate with NPI, procurement, and production to qualify new suppliers and monitor ongoing performance.

The role requires a manufacturing/engineering background, GMP/ISO13485 knowledge, and strong analytical skills. Experience with audits and change controls is valued.

Qualifications

• Bachelor's degree in Engineering (Manufacturing, Mechanical, Biomedical, or related).
• Strong knowledge of GMP, ISO 13485, and regulatory requirements.
• IRCA Lead auditor or equivalent certification is an advantage.
• Good analytical and problem-solving skills.
• Strong communication and training abilities.
• Ability to work cross-functionally and manage multiple tasks.

Responsibilities

• Review SQE work output, including supplier CAPA, audit reports, and supplier performance data.
• Oversee supplier qualification, onboarding, and ongoing performance monitoring.
• Lead and support supplier audits and ensure timely closure of findings.
• Escalate unresolved or high-risk supplier issues to QA manager with recommended actions.
• Collaborate with cross-functional team (NPI, procurement, production) to qualify new suppliers.
• Work with quality control to address supplier quality issues and support disposition of rejects.
• Support supplier-related change control activities.
• Participate and lead internal meetings related to supplier quality and improvement projects.
• Prepare annual reports on supplier quality performance for management review.
• Support audits by providing supplier quality data and evidence.
• Review and improve supplier quality procedures, work instructions, and forms.

Skills

SQE experience

Supplier quality

Audits & CAPA

Data analysis

Cross-functional collaboration

Communication skills

Training & mentoring

Problem solving

Education

Bachelor's Degree in Engineering

Job description

Coach SQE on daily tasks, problem-solving, and supplier communication.

Review SQE work output, including supplier CAPA, audit reports, supplier performance data, and follow-up actions.

Oversee supplier qualification, onboarding, and ongoing performance monitoring processes.

Lead and support supplier audits and ensure timely closure of findings.

Escalate unresolved or high-risk supplier issues to QA manager with recommended actions.

Collaborate with cross-functional team (NPI, procurement, production) to qualify new suppliers and material qualification.

Work with quality control to address supplier quality issues and support disposition of supplier-related rejects.

Support supplier-related change control activities.

Participate and lead in internal meetings related to supplier quality, production quality issues, customer complaints, and improvement projects.

Prepare annual reports on supplier quality performance for management review.

Support internal and external audits by providing supplier quality data and evidence.

Review and improve supplier quality procedures, work instructions, and forms when required.

Education

Bachelor’s Degree in Engineering (Manufacturing, Mechanical, Biomedical, or related field)

Strong knowledge of GMP, ISO 13485, and regulatory requirements

IRCA Lead auditor or equivalent certification is an advantage

Good analytical and problem-solving skills

Strong communication and training abilities

Ability to work cross-functionally and manage multiple tasks

Straits Orthopaedics (Mfg) Sdn Bhd ("Straits") is a situated at Batu Kawan. Straits is a medical devices manufacturer and our principal business is the production, cleaning and packaging of orthopaedics devices and accessories (trauma and reconstructive ) and wound care products. Mainly, all our product are exported to our customers in the United States of America, China, Japan, Europe etc. Straits is a company certified with ISO 13485 and ISO 9001. Our company is registered with US FDA and is required to comply with 21 CFR Part 820. Currently, we have approximately 1200 employees and due to our expansion, we are looking for qualified candidate to join our team as :

Straits Orthopaedics (Mfg) Sdn Bhd ("Straits") is a situated at Batu Kawan. Straits is a medical devices manufacturer and our principal business is the production, cleaning and packaging of orthopaedics devices and accessories (trauma and reconstructive ) and wound care products. Mainly, all our product are exported to our customers in the United States of America, China, Japan, Europe etc. Straits is a company certified with ISO 13485 and ISO 9001. Our company is registered with US FDA and is required to comply with 21 CFR Part 820. Currently, we have approximately 1200 employees and due to our expansion, we are looking for qualified candidate to join our team as :

What can I earn as an Assistant Quality Assurance Manager