Component Quality Assurance Engineer
Michigan, Kalamazoo-Battle Creek
Our client, a Global Medical Device Manufacture has an immediate opening for a Component Quality Assurance Engineer for a 9 Month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
Defines and implements quality control processes to measure product or service compliance to design specifications. Creates and conducts sampling and testing procedures. Identifies root causes for defects and participates in continuous improvement initiatives. Understands and uses statistical process control techniques. Prepares documentation of findings and recommendations. Develops new processes and tools as needed in order to improve testing execution and impact.
PPAP experience is a must.
Component Qualification experience is a must.
Medical Device experience is preferred but not required
Partner with marketing and design to understand user needs and translate those into engineering specifications that constitute the basis of the design
Lead the development of a safety risk management strategy including implementation of risk controls
Partner with suppliers and manufacturing to implement robust process controls
Develop test protocols that represent real-world use scenarios to verify design inputs
Lead component qualification and inspection development activities with suppliers
Lead design validation activities including human factors engineering
Monitor compliance to Quality Procedures and FDA Quality System Regulations (QSR s) as well as all other product-specific standards/regulations and guide the team as necessary
Bachelor of Science in Engineering - GPA of 3.0 or higher
Ability to think critically, solve complex problems, and work on large cross functional and diverse teams
Experience within medical device/manufacturing industry preferred
Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard) preferred
Data analysis (statistical analysis, sampling plans, statistical process control, Minitab) experience is preferred
Experience with development and implementation of design and process controls, geometric dimensioning & tolerancing, and industrial statistical techniques is preferred
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