Quality Engineer II

Careers That Change Lives

We value what makes you unique. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

In this exciting role as a Senior Quality Engineer, you will have responsibility for coordinating, and managing the quality assurance (QA) activities associated with one or multiple New Product Development (NPD) projects to ensure compliance to internal and external requirements during the development and commercialization of new products. This individual will provide QA leadership and partner with the NPD organization in efficient, effective, and rapid development and commercialization of new products. This individual will manage the effective oversight of NPD QA activities, as well as participate as an active QA representative on project teams. The Senior QE manages the daily operation of the NPD quality aspects of one or multiple projects by ensuring timely completion of NPD Quality Assurance deliverables that meet the company standards for quality. This individual provides the project teams with clear, consistent, and timely feedback as it relates to compliance exposure and will provide innovative solutions to effectively resolve investigations and to meet the needs of customers, regulatory bodies and Medtronic business requirements.

SPECIALTY THERAPIES offers a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose, and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.

This position is in Jacksonville, FL.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in the Life

In general, the following responsibilities apply for the Quality Engineer II r ole. This includes, but is not limited to the following:

• 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.
• Leads cross functional team on how to documents changes, using a risk-based approach for determining requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions.
• Provide training and support for quality system processes and quality engineering practices.
• Performs analytical measurements and experiments to qualify or resolve product and process issues.
• Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Qualifications –

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s Degree in Engineering, Science, or technical discipline with 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science, or technical discipline with 0+ years of work experience in Engineering and/or Quality.

Nice to Have

• 2-5 years direct experience in a Product Development or R&D Organization
• 6+ years of experience in a similar role within the Medical Device Industry
• Strong communication skills both verbal and written.
• Strong organizational skills as well as time management skills essential for project work
• Self-motivating and able to balance multiple priorities and tight deadlines with minimal supervision
• Experience using quality tools and statistical programs like Minitab, risk assessment (FMEA), experimental design (DOE) and process improvement (SPC) is required.
• Excellent computer skills
• Strong writing, mathematics, and statistics skills
• Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards.
  

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)