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Medtronic Quality Systems Specialist-Mumbai in India

About the job

At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Our Purpose

For our Service Operations Supplier Quality team, we are looking for a new team member to strengthen our team. This role will support the organization with day-to-day requirements related to supplier Management. This role will act as first level support for stakeholders and commercial areas involved in the acquisition of new suppliers to support the company operation.

A Day in the Life

Responsibilities may include the following and other duties may be assigned:

· Supplier Performance & Relationship Management:

o Serve as subject matter expert for supplier Management process.

o Support users with supplier selection, evaluation and segmentation as per Medtronic supplier management procedures and own and maintain the related required supplier files in the document management system.

o Own and maintain Approved Supplier List (ASL) in the document management system.

o Provide constant updates to the leaders, stakeholders or partners responsible for the supplier approval.

o Prepare, update and monitor audit / performance evaluation schedules for supplier management process.

o Investigate poor supplier performance ratings to identify causes and works with the supplier to implement improvements.

o Ability to effectively identify root cause and coordinate with supplier to ensure corrective & preventive actions through the (Supplier) CAPA process.

o Provide guidance for supplier change requests, including communication, project management via document management system and regular reporting.

o Provide analytical support for key metrics and periodic reporting to update internal stakeholders on the status of supplier management (i.e. # of new suppliers, # of supplier changes, # of SCAPA, etc.).

o Manages relationship with external suppliers to effectively represent Medtronic to the supplier, and appropriately represent the supplier to Medtronic, deliver best value and provide competitive advantage.

o Train and mentor any supplier if needed.

o Ensures supplier meets obligations agreed by contract.

· Quality Systems/Standards:

o Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.

· Compliance:

o Operate within compliant quality system environments.

o Participate and support internal / external Supplier and Quality System Audits in in the regions supported.

· Continuous Improvement:

o Be a change agent for the organization. Identify, facilitate, and implement changes to improve efficiency, compliance and reduce complexity of processes as required.

· Systems and Tools :

o Leverages the business specific tools and systems used throughout Operations at Medtronic for optimal decision-making.

o Uses ERP system (SAP) to conduct normal duties, generate metrics.

o Demonstrates proficiency in applicable software tools such as MS Excel and Business object.

· Commercial Agreements:

o Supports drafting and execution of pertinent written agreements/documents for ongoing requirements, such as purchase orders, and Memoranda of Agreement etc.

o Understands the implications of different types of commercial agreements. Chooses the appropriate agreement for the circumstances.

Must Have: Minimum Requirements

  • Bachelor’s degree required.

  • Minimum of 2 years of relevant experience in Engineering and/or Quality experience in the medical industry or related field, or advanced degree with 0 years of experience.

  • You are a dynamic team player and can work effectively and proactively on cross functional teams.

  • You are a good communicator and fluent in English, both verbal and written.

  • Evening shift.

Nice to Have

· Certified Quality Auditor certification.

· Previous experience supporting quality system audits.

· Strong technical writing and documentation review skills.

· Strong critical thinking and analytical skills.

· Independent compliance decision maker (based on knowledge of regulations, available relevant information, alternatives, risk).

· Good understanding of the Medical Device Regulations and the Food and Drugs Acts as pertinent to the position.

· Working knowledge of ISO 13485, and Medical Devices regulations/guidance on the Control of Products and Services obtained from Suppliers

· Good understanding of FDA regulations for Medical Devices and Drugs regarding Complaint Handling/Mandatory Medical Devices Problem Reporting, Adverse Events reporting and Recalls (basic understanding of International regulations).

· Certified Quality Engineer, Reliability Engineer, or equivalent desired.

· Influence management skills; ability to work constructively across all functions of the organization and build relationships

· Experience writing and reviewing of technical documentation.

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 healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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