Senior Quality Engineer
We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide. Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way that’s best for you.
Together, we can confront the challenges that will change the face of healthcare. Join us for a career that change lives. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.
In this exciting role as senior supplier quality engineer in Neuroscience portfolio, you will have primary focus responsibility on New Product Introduction and Legacy product. You will interact daily with cross functional team members to ensure business objectives are carefully adhered to. A comprehensive list of the day in the Life is listed below:
The Neuroscience portfolio develops therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
As a Senior supplier quality engineer you will be a key member of the Medtronic Quality Engineering team and responsible for coordinating suppliers and verifying quality standards in accordance with the company requirements .
A Day in the Life
As a Senior supplier quality engineer , you will:
· Responsibilities may include the following and other duties may be assigned.
· Qualify suppliers according to company standards & management of approved supplier list per purchasing control compliance
· Initiate and drives SCAPA’s/NCR to supplier not performing/or adhering to company standards. Manage supplier change requests
· Assess supplier performance on periodic basis & drive necessary action for continous improvement
· Established a process & ensures that suppliers deliver quality parts, materials, and services.
· Lead PPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ & PQ methodology
· 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.
· Provide 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.
· Collaborates with component engineers to develop and deliver the product acceptance sampling strategy, approved supplier list coordination, supplier owned quality deployment, PFMEA,MSA, ,Control Plans and relevant quality tools and methodologies for new products and legacy product.
· Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
· Conduct audits to qualify supplier’s for intended use for the business
Must Have: Minimum Requirements
Must Have:
· Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 8 to 12 years of quality systems experience. Experience in supplier management is added advantage
· Strong communication skills, both oral and written
· Ability to comprehend principles of engineering, physiology and medical device use
· Previous customer-facing and/or project management experience is a plus
· Previous experience working with global team
· Comfortable working with international and multi-cultural department and groups in different time zones .
Accurate and delivers quality work, with a sense of urgency
Nice to Have
· Good interpersonal skills
· Ability to work in a fast-paced environment
· Ability to work well under pressure and maintain positive, enthusiastic attitude
· Eagerness to learn and expand responsibilities & accountablity
· Ability to work effectively in a team environment and build strong working relationships.
· ASQ Quality certification – CQE, CSQP, CQA
· Working knowledge of Standard, Guidance, and Regulations
· Hand on experience on Minitab tools
· Exposure in auditing to FDA Quality System Regulation & ISO 13485
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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)
