Design Quality EngineerBe an expert for your team, be an asset to Design and Operations, and be able to influence high-visibility projects while being in control of your schedule. This role is for a high achiever who likes variety everyday and solving problems in tight deadlines. You will be able to have a direct and immediate impact on the quality of products being delivered to our customers. Your name will be attached to the performance of high quality medical devices that will change peoples' lives.
Overview
The Senior Quality Engineer will be required to take a leading role, technically, in root cause problem solving and resolution of top quality issues identified in the field and in production. The Senior Quality Engineer will lead the identification of potential failure modes and risks, and the development of quality assurance practices and controls for current product. An area of concerns is building relationships with several different functional groups including Operations, Design Engineering, Marketing, and the Post Market Team and implementing product improvements and process controls to enhance product quality.
Organization
The Senior Quality Engineer will report to the Quality Team Leader of the assigned business unit. The team includes one other Quality Engineer, one Quality Technician, and three Advanced Quality Engineers. The Senior Quality Engineer will also work closely with Regulatory Affairs.
Performance Objectives
1. Within 60 days, plan, the successful employee will have built relationships with the cross functional team, understand the products, learn the Quality System, and become familiar with the top quality issues within the assigned product line. Also, this person will quickly respond to, investigate, and resolve quality issues on the production floor.
2. Within the first 90 days, the successful employee will begin to play a key role in product improvement initiatives and have a working understanding of the Quality System, being able to navigate and abide by the requirements of the Quality System for resolving quality challenges.
3. In the first 6 months, the successful employee will successfully manage time while balancing multiple priorities, be a valuable team player, and take a leadership role in problem solving and in the development, verification, and validation of lasting solutions to quality challenges.
Experience
The person selected for this position should have at a minimum of 2 years of developing quality assurance practices and controls. Specific experience should include root cause problem solving demonstrated integrity and a passion for quality, and a track record of meeting project goals by working with cross-functional teams across an organization. This person should have some experience developing and implementing appropriate test protocols, understanding and mitigating risk, and a background in structured problem solving methodologies. A BS degree in Mechanical or Electrical Engineering or related discipline is preferred.
Would you want to have the opportunity to use your problem solving skills while impacting people's lives for the better? The role will give you autonomy and responsibility within business to investigate and resolve quality challenges on current products. You will also be able to help the team navigate roadblocks, while always being an advocate for product quality. You will be able to stretch your mechanical aptitude with analysis of design reviews, test failures, and project management. This is a fantastic career growth opportunity for an engineer ready for the next great challenge.
PHYSICAL/SAFETY REQUIREMENTS:
•May involve prolonged periods of stooping, kneeling, crouching, bending, sitting, standing, and/or crawling as appropriate
•May be required to move equipment up to 50 pounds, reach, push, or pull in order to accomplish job accountabilities
•Coordination of eye, hand, and/or foot movement with an ability to grasp by hand and meet cognitive demands
•Requires use of safety glasses in designated areas
•Closed-toe shoes must be worn on the production floor
Qualifications/Work Experience
• Minimum of 2-3 years experience in field of specialization
• Achieved a advanced (learning) level of industry knowledge
• Manage projects in a timely manner
• Ability to conduct and document technical investigation
• The following experiences/skill sets are highly desirable:
o ISO 13485 and ISO 14971
o Industrial statistical techniques
o Development and implementation of design and process controls
o GD&T
Education and/or Special Training
• Bachelors Degree in science or engineering
• Minimum of 2-3 years experience in field of specialization
• Achieved a advanced (learning) level of industry knowledge
Percent Travel Required
10
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