- 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.
- 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. Must Have: Minimum Requirements
- Bachelors degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience Nice to Have
- Engineering bachelor's degree is a must
- Knowledge in Project Management
- Knowledge in Validation process (IQ/OQ/PQ/TMV)
- Excellent interpersonal and communication skills in English and Spanish
- Negotiation skills
- Knowledge in GMP and GDP
- Strong statistical knowledge
- Experience in regulated industry.
- Knowledge in change control process
- Knowledge in injection molding
Sr Supplier Qual Engineer - Ponce, Puerto Rico - Medtronic
Descripción
Careers that Change LivesA career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.
A Day in the LifeResponsibilities may include the following and other duties may be assigned.