Supplier Quality Engineer

Abbott Penang (Formerly Known as St. Jude Medical); Bayan Lepas; Sur place; MYR 60 000 - 120 000; Plein temps

Résumé du poste

Abbott Penang (Formerly Known as St. Jude Medical) is seeking a Supplier Quality Engineer to ensure supplier quality performance aligns with manufacturing requirements and to support continuity of operations.

The role acts as the primary liaison between suppliers, sister sites, and internal teams to resolve quality issues, drive corrective actions, and support qualification activities for components and suppliers in a dynamic medical device environment.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, Science, or related discipline.
• 2-5 years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or related field.
• Knowledge of quality management systems, root cause analysis methodologies, and corrective action processes.
• Familiarity with quality tools and methodologies such as 8D, CAPA, FMEA, SPC, MSA, and statistical analysis techniques.
• Strong analytical, problem-solving, communication, and stakeholder management skills.

Responsabilités

• Serve as the primary quality interface between suppliers, sister sites, and internal stakeholders on supplier-related quality matters.
• Support incoming quality issues, material nonconformances, and operational escalations related to incoming materials or components.
• Investigate supplier quality issues, coordinate containment activities, and drive timely resolution to minimize manufacturing and supply chain impact.
• Initiate and drive NCMR, SCARs to closure, ensuring effective root cause analysis and corrective actions.
• Monitor supplier quality performance metrics and drive continuous improvement with suppliers.

Connaissances

Analytical thinking

Problem-solving

Stakeholder management

Communication

Quality Engineering

Formation

Bachelor's Degree in Engineering or related

Outils

8D

CAPA

FMEA

SPC

MSA

Description du poste

The Supplier Quality Engineer (SQE) is responsible for ensuring supplier quality performance meets organizational requirements and supports the continuity of manufacturing operations. This role serves as the primary liaison between suppliers, sister sites, and internal cross-functional teams to resolve supplier-related quality issues, drive corrective actions, support component and supplier qualification activities.

Key Responsibilities

• Serve as the primary quality interface between suppliers, sister sites, and internal stakeholders on supplier-related quality matters.
• Support incoming quality issues, material nonconformances, and operational escalations related to incoming materials or components.
• Investigate supplier quality issues, coordinate containment activities, and drive timely resolution to minimize manufacturing and supply chain impact.
• Initiate and drive Non-Conforming Material Report (NCMR), Supplier Corrective Action Requests (SCARs) to closure, ensuring effective root cause analysis and implementation of corrective and preventive actions.
• Monitor supplier quality performance metrics and work with suppliers to drive continuous improvement and achieve quality objectives.
• Collaborate with Engineering, Production, Supply Chain, Procurement, and other cross-functional teams to address supplier quality concerns and implement effective solutions.
• Support qualification and validation activities for alternate components, materials, suppliers, and manufacturing processes, including risk assessments and documentation reviews as required.
• Review, assess, and coordinate supplier change notifications, ensuring appropriate impact assessments and approvals are completed.
• Support supplier audits, assessments, and qualification activities as required.
• Provide quality engineering support for operational and manufacturing-related quality issues as required.
• Perform other duties and responsibilities as assigned by the supervisor or management.

We Are Looking For

• Bachelor's Degree in Engineering, Quality, Manufacturing, Science, or a related discipline.
• Minimum 2-5 years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality, or a related field.
• Knowledge of quality management systems, root cause analysis methodologies, and corrective action processes.
• Familiarity with quality tools and methodologies such as 8D, CAPA, FMEA, SPC, MSA, and statistical analysis techniques.
• Strong analytical, problem-solving, communication, and stakeholder management skills.
• Ability to work effectively with suppliers, external partners, and cross-functional teams in a dynamic manufacturing environment.
• Proficient in Microsoft Office applications and quality management systems.
• Self-motivated with the ability to manage multiple priorities and projects simultaneously.
• Knowledge of Printed Circuit Board Assembly (PCBA) manufacturing processes, electronic components, and quality requirements is preferred.
• Knowledge of medical device quality systems and regulatory requirements (e.g., ISO 13485, FDA Quality System Regulation) is preferred.