Quality Engineer II
Nanakramguda, Hyderabad, India
4 hours ago
Careers that Change Lives:
Were 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. Well support you with the training, mentorship, guidance, and networks you need to advance, and empower you to work in the way thats 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:
TheNeurovascular 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 suppliren according to company standards management of approved supplier list per purchasing control
Initiate and drives SCAPAs/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
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
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. Lets 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)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)
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.