Sr Supplier Qual Engineer- Remote, Guadalajara, Mx

hace 2 semanas

Guadalajara, México Medtronic A tiempo completo

**Careers that Change Lives**

In this exciting role as a **Sr. Supplier Quality Engineer **, you will be responsible for the managem ent of our strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) at Medtronic, with accountability to support changes to existing supplied products and processes, as well as oversight of performance and improvement activities. While partnering with our CMs and OEMs, including sub-tier suppliers as required, this position is responsible for maintaining necessary controls and drive improvements relating to finished medical device / component quality in conjunction and within our suppliers’ quality systems.

You will work in partnership with the internal Medtronic R&D, Quality, and Regulatory teams, to ensure our supplied products conform to finished device requirements, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products while staying in compliance to applicable industry standards, regulatory requirements, and customer requirements.

Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.

**A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Work with Medtronic’s strategic CM/OEM suppliers to lead and drive systematic approaches to medical device quality issues.
- Coordinate and monitor change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented.
- Oversee changes to processes/products currently in production to aid in the correction of process, design or material problems (as well as changes associated with sub-supplier and material changes). Lead quality process improvements and streamlining activities.
- Review/prepare test plans and reports (qualification, validation) for change and improvement activities (supplier certifications, material/sub-supplier changes and supplier performed special processes).
- Work with sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality.
- Ensure the resolution of all issues raised during testing/qualification.
- Drive corrective/preventative actions at our CMs/OEMs based on feedback from incoming inspection, production defects, Medtronic/supplier internal quality metrics and customer complaints.
- Supports Corporate and external (FDA, TUV, BSI, etc.) quality and compliance audits of the CM/OEM products and/or the supplier’s Quality Management System.
- Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements.
- Support / Lead sustaining engineering projects that may involve manufacturing process transfers, label/IFU updates, sub-supplier qualification, performance testing (verification and validation), and design qualification.
- Participate in the audit/assessment of current or future suppliers/contract manufacturers ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements.

**Must Have: Minimum Requirements
- Bachelor's degree in engineering required
- Minimum 4 years of relevant experience.
- Advance English

**Nice to Have**
- 4+ years of supplier quality experience in the medical device industry or related field with supplier quality management experience
- Experience supporting manufacturing processes including printed circuit board assembly, manual assembly, machining, molding (dip/injection), etc.
- Demonstrated working knowledge of supplier controls, process validation, failure investigation techniques, nonconforming product controls, and protocol/report generation
- Project Management experience
- First Time Quality (FTQ) Coach or Six Sigma / DFSS / Lean Green Belt
- Quality System Lead Auditor experience (ISO 13485)
- Working knowledge of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)
- Strong Oral and Written communication skills (English and Spanish)
- Ability to work in a team/partnership environment
- Computer Skills (Microsoft Word, Excel, Project, PowerPoint; Trackwise; Agile)

**About Medtronic
**Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal

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