Supplier Qual Engineer I

Descrizione del lavoro:

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
In this exciting role as a Supplier Quality Engineer I, you will be responsible for supporting the oversight of manufacturing which occurs at the Medtronic strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs), with accountability to support changes to existing supplied products and processes, as well as oversight of nonconformances and complaint investigations performed by the suppliers. 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 management systems.

You will work in partnership with the internal Medtronic R&D, Quality, and Regulatory teams, primarily in the Cranial & Spinal Technologies operating unit, 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.
* Ensures that suppliers deliver quality parts, materials, and services.
* 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); leveraging the Production Part Approval Process (PPAP) when required.
* Work with sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality.
* Drive resolution of all issues raised during testing/qualification.
* Manages Nonconformances from investigation through disposition in collaboration with suppliers and internal Medtronic partners.
* Ensure appropriate rigor in responses to Medtronic customer complaints, including oversight of Supplier investigation into the allegation
* 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.

Nice to Have (Preferred Qualifications)
* Bachelor's degree in Engineering, Science, or technical field with 2+ years' experience in Medical Device and/or Capital Equipment OR Advanced degree in Engineering, Science or technical field with experience in Engineering or Quality.
* 2+ years of supplier quality experience in the medical device industry or related field with supplier quality management experience
* Strong Oral and Written communication skills (English and Spanish)
* Proven ability to work in a internal/external team environment
* 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
* Working knowledge of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)
* Computer Skills (Microsoft Word, Excel, Project, PowerPoint; Agile)

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Autonomy: Entry-level individual contributor on a project or work team. Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.
Leadership and Talent Management: N / A - job at this level is focused on self-development.
Required Knowledge and Experience: Requires a Baccalaureate degree and 0 years relevant experience.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here