職位描述
Main Purpose:
? Responsible to assure that manufacturing processes comply with the product specification and regulatory government agencies requirements. Provide mechanisms for controlling the total quality and establish ways of evaluating the quality of our products. Participate on internal, interfacility and vendors/suppliers quality audits to determine the extent of compliance and effectiveness of operations, to documented policies, procedures, specifications, FDA and ISO requirements.
Key Accountabilities:
? Assure that processes comply with specifications, Quality Systems Regulations and ISO standards.
? Document that processes complies, with a high confidence level, the tolerances stated on the product specification and drawings.
? Establish mechanism to evaluate, measure, monitor and/or quality in our products.
? Evaluate product/material discrepancies. (PRB/MRB) on time, and implement corrective actions accordant.
? Work on new product transfers and actively participate in the qualifications and validations of product/equipment and processes.
? Provide check and balance to manufacturing/system changes submitted by manufacturing Engineers.
? Work on special projects assigned by Supervisor/Manager.
? Support manufacturing activities by also participating on production meetings.
? Update manufacturing processes in order to reflect quality concepts and specification requirements.
? Apply statistical tools in order to assure that processes comply with the specifications.
? Ensure compliance to audit findings in a timely manner.
? Coordinate qualification and validation activities for all product and technology transfers.
? Participate on internal quality audits by reading and understanding the audit plan, check list, and performing initial meetings with auditor. Participate in the generation of the written report of findings and in the wrap-up responses to assure corrective actions are implemented.
? Evaluate/Approve Engineering change request/orders.
? Conduct failure investigations in order to initiate, stimulate, and assign corrective action. Issue written reports and update, accordingly.
? Provide engineering counseling to less experienced engineers.
? Promote an ethical behavior.
Attributes:
? Flexibility and adaptability
? Team work
? Detail oriented
? Patience and perseverance
Experience and Knowledge:
? Minimum 3 years experience in Engineering related to manufacturing of small electro/mechanical devices preferably in a quality assurance or test related capacity.
? Must have an aggressive practical personality capable of recognizing problems, causes, and solutions.
? Vision: 20/20 or restored vision.
? Proven evidence of The Medtronic Traits:
- Global
- Mission values
- Compliance and Integrity
- External focus
- Clear thinking
- Driven to win
- Inspires others
- Executes
- Boundaryless
Qualifications:
? Bachelor Degree in Engineering or equivalent
