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Job Information
Medtronic Quality Systems Specialist-Mumbai in Mumbai, India
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
Responsibilities may include the following and other duties may be assigned.
Serve as subject matter expert for supplier Management process.
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.
Own and maintain Approved Supplier List (ASL) in the document management system.
Provide constant updates to the leaders, stakeholders or partners responsible for the supplier approval.
Prepare, update and monitor audit / performance evaluation schedules for supplier management process.
Investigate poor supplier performance ratings to identify causes and works with the supplier to implement improvements.
Ability to effectively identify root cause and coordinate with supplier to ensure corrective & preventive actions through the (Supplier) CAPA process.
Provide guidance for supplier change requests, including communication, project management via document management system and regular reporting.
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.).
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.
Train and mentor any supplier if needed.
Ensures supplier meets obligations agreed by contract.
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.
Operate within compliant quality system environments.
Participate and support internal / external Supplier and Quality System Audits in in the regions supported.
Be a change agent for the organization. Identify, facilitate, and implement changes to improve efficiency, compliance and reduce complexity of processes as required.
Leverages the business specific tools and systems used throughout Operations at Medtronic for optimal decision-making.
Uses ERP system (SAP) to conduct normal duties, generate metrics.
Demonstrates proficiency in applicable software tools such as MS Excel and Business object.
Supports drafting and execution of pertinent written agreements/documents for ongoing requirements, such as purchase orders, and Memoranda of Agreement etc.
Understands the implications of different types of commercial agreements. Chooses the appropriate agreement for the circumstances.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. 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 and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy: Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
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.
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.
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 90,000+ 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 (http://www.medtronic.com)
Welcome to our new Careers Site!
If you applied before July 22nd, please check your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your current activity. If you do not see an email from us, please feel free to proceed with creating a new account.
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 90,000+ 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.
We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
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.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email AskHR@medtronic.com
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