Senior Quality Engineer.

4 weeks ago

Hyderabad, India Medtronic Full time
Careers that Change Lives

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 assenior supplier quality engineer in Medical surgical portfolio, you will have primary focus responsibility including new product introduction and legacy product remediation. You will be a key member of the Medtronic quality engineering team and responsiblefor 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’s to suppliers not performing/or adhering to company standards. Manage supplier change requests .

·Assess supplier performance on periodic basis & drive necessary action for continous improvement.

·Establish 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 andrelevant quality tools and methodologiesfor 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

·Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 8 to 12 years of quality systems experience. Experience in supplier management in medical domain 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.

·Comfortable working with international and multi-cultural department and groups in different time zones . 

Accurate and delivers quality work, with a sense of urgency.

·Ability to work well under pressure and maintain positive, enthusiastic attitude.

·Ability to work in a fast-paced environment .Eagerness to learn and expand responsibilities & accountablity .


Nice to Have

·Good interpersonal skills.

·Previous experience working with global team (Aerospace,Defence, Med device, automobile preferably).

·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 toFDA Quality System Regulation & ISO 13485.

Lean Six Sigma Green Belt or Black Belt.

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