Senior Quality Engineer

JOB TYPE: Full Time, Employee JOB CATEGORY: Quality Assurance/Safety CITY: Redmond STATE: WAAbout Medtronic Benefits and Total Rewards It's challenging. It's energizing. It's rewarding. That's why our nearly 38,000 employees have chosen to spend their careers at Medtronic, a global leader in medical technology, providing lifelong solutions for people with chronic disease. Today, every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. Join us in our mission to alleviate pain, restore health and extend life, and discover why FORTUNE magazine named us one of the "100 Best Companies to Work For" eight of the last 10 years. Senior Quality Engineer GENERAL SUMMARY:Leads quality activities to support the lifecycle of the product. Develops, evaluates, and implements protocols/ methods to inspect and test in-process raw materials and finished while ensuring they are in compliance with both company quality assurance standards and applicable government regulations. Maintains knowledge of new developments and technology. Monitors products, processes, and projects within assigned product line and recommends changes to improve operating efficiency and quality. MAJOR DUTIES/RESPONSIBILITIES:1. Ensures compliance to in-house and external specifications and standards, such as current Good Manufacturing Practices (cGMPs) and International Organization for Standardizaton (ISO) regulations.2. Performs analysis and identifies trends in inspection of finished products, in-process materials, and bulk raw materials, and recommends corrective actions and process improvements.3. Performs analysis and identifies trends in product field performance and recommends corrective actions and process improvements.4. Evaluates and analyzes the efforts in organizing, documenting, and interpreting inspection support documents and records.5. Ensures that established manufacturing inspection, sampling and statistical process control procedures are followed.6. Represents quality on various business teams to support product and process improvement.7. Represents quality during protocol development that ensures products and processes are designed, developed, transferred, and commercialized to meet appropriate regulations and business outcomes.8. Contributes to the definition of quality system policies.9. Perform other related duties as assigned. BASIC QUALIFICATIONS· Bachelor of Science degree or foreign equivalent in an engineering discipline and five years of progressive experience in Quality Engineering· Advanced study in the quality sciences as evidenced by Certified Quality Engineer certification and/or green or black belt in either six-sigma or design for six sigma· Prior experience in a Food and Drug Administration (FDA) regulated environment, with knowledge of current FDA Quality System Regulations and ISO 13485 or 9001· Experience with Validation, Verification and Qualification Activities in a cGMP environment· Experience with PFMEA (Process Failure Modes and Effects Analysis), Control Plan , MSA (Measurement System Analysis) & GR&R (Gage Repeatability and Reproducibility) studies· Strong analytical skills with a strong emphasis on statistical analysis· Strong technical writing skills· Excellent written and verbal communication skills PREFERRED/DESIRED QUALIFICATIONS· Master of Science in an engineering discipline highly preferred· Proficient use of electrical, mechanical, or environmental procedures, quality control testing equipment and methods· Demonstrated proficiency in project management and standard project management tools (such as MS Project) with proven leadership skills WORKING CONDITIONSFast-paced office environment with some exposure to a manufacturing environment; significant use of computer equipment; minimal travel may be required.   To Apply: Click Apply Now to route your resume directly to the hiring department. No agencies or phone calls, Please Medtronic is an euqal opportunity employer committed to cultural diversity in the workforce. www.medtronic.com/employment   Click here to see other Medtronic opportunities  Email this Job to a Friend