Key skills
Supplier Quality EngineeringMedical Devices IndustryDistribution Centers3PL SuppliersSAPAgileTrackwiseApproved Supplier List (ASL) ManagementQuality Agreements NegotiationSupplier AuditingValidation and QualificationCertified Supplier ProgramReceiving InspectionSupplier CAPA ProcessManufacturing Practices (GMP)Pre-Market Quality EngineeringNew Product Development (NPD) SupportPost-Market Supplier QualityTest Method ValidationBilingual English and SpanishCommunication
About this role
FITS, LLC is a Service Provider company that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services. They are seeking a Senior Supplier Quality Engineer to support the Supplier and Distribution Quality organization, ensuring suppliers deliver quality parts and materials while monitoring performance and conducting audits.
Responsibilities:
- Support the Supplier and Distribution Quality organization to identify and establish the Approved Supplier List (ASL) for Distributors and 3PL's, negotiate Quality Agreements, monitor the performance, develop and execute the audit schedule, as well as supporting on validation and qualification activities with these suppliers
- Ensures that suppliers deliver quality parts, materials, and services
- Qualifies 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 communicates and resolves supplier-related problems as they occur through the Supplier CAPA process
- 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
- 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, Post-Market Supplier Quality and Distribution Teams, to deliver quality parts, materials, and services, prevent defects, to provide customers with the highest quality and reliable products
- Collaborates with Distribution in the selection of new Distributors and 3PLs
- Define Receiving Inspection requirements as required and associated test method validation
Requirements:
- Bachelor's degree in Engineering and a minimum of four (4) years of relevant experience, or an advanced degree with a minimum of two (2) years of relevant experience within the medical devices industry
- Bilingual (English & Spanish)
- Experience in Distribution Centers and 3PL's suppliers
- Experience in Leading Projects
- Experience in SAP, Agile and Trackwise desired
- Excellent communication skills
- Ability to ask for help when needed
- Excellent Maintenance skills
- Love of the scientific method
- Teamwork skills
- Ethical behavior