Sr Quality Engr

A Day in the Life Careers that Change Lives 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 RD 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
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 , your primary focus responsibility will be managing suppliers for released product engineering and manufacturing transfers by ensuring suppliers qualification documents are in accordance with the company requirements . You will be a key member of the Medtronic quality engineering team and responsible for coordinating A Day in the Life As a senior supplier quality engineer you will be :

• 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 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.

Required knowledge, experience skills :

• 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.
• 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 .

Skills - Nice to have :

• Good interpersonal skills.
• Previous experience working with global team (Aerospace, Defence, Med device, automobile preferably).
• Previous customer-facing and/or project management experience is a plus.
• Ability to work effectively in a team environment and build strong working relationships.
• ASQ Quality certification - CQE, CSQP, CQA.
• Working knowledge of Agile MAP PLM system, Standard, Guidance, and Regulations.
• Hand on experience on Minitab tools to perform statistical analysis.
• Exposure in auditing to FDA Quality System Regulation ISO 13485.
• Lean Six Sigma Green Belt or Black Belt.

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. Benefits Compensation About Medtronic