Senior Quality Engineer

Job Description

Quality EngineerCareers 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 as Design Quality Engineer in Neurovascular portfolio, you will have primary focus responsibility on DHF remediation & Supplier Quality activities. 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 Neurovascular 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.A Day in the Life:Responsibilities may include the following and other duties may be assigned.

• Qualifies suppli ren according to company standards & management of approved supplier list per purchasing control
• Initiate and drives SCAPA s/NCR to Supplier not performing/or adhering to company standards
• Evaluate supplier performance on periodic basis & take necessary action for continous improvement .
• Ensures that suppliers deliver quality parts, materials, and services.
• Prepare plan for 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.
• Collaborates with cross functional team to manage Approved Supplier List coordination, Supplier Owned Quality deployment, PFMEA and Control Plans for legacy product.
• Participate with cross-functional teams to review DHF files & techanical files, identify gaps & drive remediation
• Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
• Ensure successful transfer of new products to production facility by assisting in the development of process validation using appropriate statistical tools and techniques.
• Any additional activities relevant to job profile may get assigned

Must Have:

• Bachelors or masters degree in Engineering with overall 8 to 12 years of experience in supplier quality & DHF remediation is recommended
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
• Good verbal and written communication skills including protocol / report development and technical presentations
• Knowledge of Risk Management standard - ISO 14971
• 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 .
• Good understanding of problem solving , MSA ,Control plans,Quality tools and methodologies
• Accurate and delivers quality work, with a sense of urgency

Nice to Haves:

• Strong communication skills, both oral and written
• 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
• Ability to work effectively in a team environment and build strong working relationships.
• ASQ Quality certification
• Working knowledge of Standard, Guidance, and Regulations
• Hand on experience on Minitab tools

Additional Information

• Posting Date: Oct 20, 2021
• Travel: No

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Keyskills :
supplier qualityiso 13485continuous improvement facilitationrisk managementinspectionquality controlproblem solvingisoquality systemppapqualityquality toolsverification validation