Senior Supplier Quality Engineer

18 hours ago

Kulim, Kedah, Malaysia AMS Full time

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 individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.

· Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to 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 as required and associated test method validation for all internal Medtronic Test Methods.

Minimum Requirements:

·       Bachelor's Degree required in engineering (biomedical, chemical, industrial, biotechnology, mechanical or related) with 4+ relevant engineering experience

Desired Skills and 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

·       Valid Passport

·       Willingness for travel for extended stays abroad (Up to 30 days at a time during 12 months time frame)


• Certification in ISO9001 and ISO13485 (Ability to audit external suppliers)


• PPAP, sampling plans


• CAD (SolidWorks, AutoCAD) interpretation and use


• Risk management


• 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


• Process validation (IQ/OQ/PQ) experience


• Technical documentation (SOPs, protocols, reports)


• Transfer of production lines


• Product design / DMR / DHF


• Experience with QMS, CAPAs, change control

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