Careers That Change Lives In this exciting role as a Quality Engineer II you will have responsibility for quality engineering support of our process development and commercial manufacturing teams. This role will provide day-to-day support to ensure high quality validation, investigation, and continuous improvement execution. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. A Day in the Life - Review equipment and process validations, test method validation, process changes, nonconformances, etc., in order to ensure compliance and assess the impact on product reliability, process capability and compliance status. - Collaborates with design, reliability, engineering, and manufacturing functions to investigate and resolve quality or compliance issues discovered during manufacturing assessments. - Support Continuous Improvement activities such as First Time Quality, Nonconformance reduction to address manufacturing quality instabilities - Utilize quality tools to support Risk Evaluation (FMEA, Fault Tree Analysis) - Communicate significant issues identified during quality activities and recommend process improvements, CAPA escalations. - Support corrective/preventive action teams in resolving production, customer and supplier issues (e.g., nonconformances, CAPA activities, audit findings) - Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. - Collaborates with engineering and manufacturing functions to ensure quality standards are in place. - Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. - Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. - Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. - May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. - Other duties may be assigned Must Have: Minimum Requirements Bachelor’s Degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality, OR advanced degree in Engineering, Science or technical field with 0 years of work experience in Engineering and/or Quality Nice to Have Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationships Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience), including presentation skills Experience with DMAIC Problem Solving/Lean Six Sigma Working understanding of relevant regulations and standards (eg 21 CFR 820, 21 CFR Part 4, ISO 13485) 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) Additional Information - Posting Date: Jun 4, 2021 - Travel: No
Apply Now