Supplier Quality Assurance Lead - Audits, CAPA & Onboarding

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

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.