Senior Supplier Quality Engineer

AMS; Kulim; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading technology firm in Kedah, Malaysia is seeking a Supplier Quality Engineer to ensure that suppliers deliver quality parts and services. Ideal candidates should possess a Bachelor's degree in engineering along with at least 4 years of relevant experience in regulated environments. Responsibilities include auditing suppliers and ensuring compliance with industry standards. The position requires effective communication skills and the ability to collaborate with multidisciplinary teams across countries, offering a significant opportunity for professional growth.

Qualifications

• 4+ years of relevant engineering experience.
• Experience in regulated environments such as medical devices or pharma.
• Intermediate-advanced English skills.

Responsibilities

• Ensure suppliers deliver quality parts and services.
• Administer Qualified Supplier Programs to ensure cost effectiveness.
• Develop an auditing schedule for supplier quality assurance.

Skills

Problem-solving

Supplier performance monitoring

Effective communication

Collaboration skills

Education

Bachelor's Degree in engineering (biomedical, chemical, industrial, biotechnology, mechanical or related)

Tools

CAD (SolidWorks, AutoCAD)

Job description

Responsibilities

• Ensure that suppliers deliver quality parts, materials, and services.
• Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicate and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers\' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Some responsibilities may include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) in partnership with the Component Engineering and Post-Market Supplier Quality Teams to deliver quality parts, materials, and services, prevent defects, and ensure high-quality, reliable products for customers.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts and implements strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Define Receiving Inspection requirements and associated test method validation for all internal Medtronic Test Methods.

Qualifications

• Bachelor’s Degree required in engineering (biomedical, chemical, industrial, biotechnology, mechanical or related) with 4+ relevant engineering experience
• Participation in at least 1 technology or process transfer project
• Experience in regulated environments (medical devices, pharma, biotechnology)
• Experience with technical documentation (protocols, reports, validations, etc.)
• Knowledge of ISO 13485 and GMP
• Understanding of change control and CAPA
• Intermediate-advanced English (reading and writing technical documents)
• Clear oral and written communication
• Willingness for travel for extended stays abroad (Up to 30 days at a time during 12 months)
• Certification in ISO9001 and ISO13485 (Ability to audit external suppliers)
• CAD (SolidWorks, AutoCAD) interpretation and use
• Problem-solving, critical thinking
• Supplier performance monitoring and improvement
• Knowledge of manufacturing processes and materials
• Effective communication and collaboration skills
• Experience working with multidisciplinary teams across countries (production, quality, regulatory, engineering)
• Participation in regulatory audits
• Transfer of production lines
• Experience with QMS, CAPAs, change control

What can I earn as a Supplier Quality Engineer