Sr Quality Engineer
Careers that Change Lives
MITG
The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.
SURGICAL INNOVATIONS set the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.
The Senior Quality Engineer is responsible for a supporting and maintaining Quality System, managing/analyzing quality non conformances, and participating in various projects and validations to assure quality considerations are adequately covered in the design, testing, and release of materials, components, and products.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
1. Supports and maintains the quality system and is able to make quality system recommendations and follow through to implementation to address issues found.
2. Work with other departments to resolve issues related to material and process quality.
3. Suggests recommendations on quality concerns, trends and costs.
4. Perform Validations (IQ, OQ, PQ, MSA, TMV, DOE) in accordance with company SOP’s.
5. Use of statistical techniques for sample size rationale, or DOE experiments, as needed.
6. Perform Root Cause Analysis for (CAPA/NCR).
7. Participates in New Product Development to assure quality considerations are adequately covered in the design, testing, and release of materials, components, and products.
8. Analyzes causes of defects and recommends or leads teams who recommend corrective actions.
9.May supervise and schedule work of Quality personnel and/or other subordinates as assigned.
10.Design methods for evaluating product quality; establishes test programs to evaluate materials, processes and products. Collect, analyze and interpret statistical data.
11.Develop Control Plans, Inspection Instructions and other documents as needed to effectively manage product/process quality.
12.Work with QA Technicians to resolve measurement, blueprint/specification issues, as needed.
13.Develop and review documented operating procedures associated with material inspection or processes.
SKILLS AND ABILITIES
- Effective analytical, technical, and problem solving skills.
- Effective planning and organizational skills.
- Effective verbal presentation skills to small and/or medium sized groups.
- Demonstrated ability to manage projects and multiple priorities.
- Demonstrated knowledge and ability to use common software tools for spreadsheet, word processing, and presentation tasks.
Must Have: Minimum Requirements
- Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality
- OR Master’s Degree Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.
Nice to Have:
- ASQ-CQE and ASQ-CQA
- Experience in FDA regulated industry
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)
