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| Location: St. Paul, Minnesota |
Posted:
02-02-2010 |
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| Category: Quality & Regulatory Affairs |
Experience: 6-9 years |
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Status: Full-Time
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Performs Mechanical engineering work requiring full competency in all conventional aspects of quality engineering. Conducts quality engineering activities of significant scope or degree of difficulty (medium-large component/system/process associated with a medium to large project). Performs most assignments independently, with only general supervision/instruction as to expected results. Writes and performs validations to introduce changes required for compliance to the QMS. Develops and performs audits to verify equipment performance. Conducts engineering activities of significant scope to validate and improve process quality. Responsible for the customer complaint investigations. Maintains communications within and outside of Business Unit in support of quality assurance engineering activities, such as project management meetings, overall quality metrics, material review, etc. Actively participates in and contributes to the decision-making process; often conducts the meeting or presentation, and makes follow-up assignments for team members. Responsible for reporting and trending field / customer complaints and returns that may result in leading CAPA investigations, risk reviews, and / or product improvement projects. Responsible for trending and taking action on Key Process Indicators of the production area that impact product quality. Oversees preparation of documentation associated with quality assurance engineering activities to include drawings/schematics, validation/capability testing, various new and revised operating procedures, etc. Plans and coordinates detailed phases of the engineering activities for part of a major project or a total project of moderate scope
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See above.
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Bachelor's degree in Mechanical Engineering or related engineering field with seven to ten years professional level experience within the medical, or a closely related industry is required. Or Masters degree in engineering, with four to six years medical, or closely related experience also meets requirements. Or Ph.D. in engineering, with three to five years medical. Cumulative GPA of 3.0, or above, in engineering major is required.
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•Possesses and applies a comprehensive knowledge of Mechanical engineering, as well as competency in related specialty fields.
•Uses considerable judgment in the planning, scheduling and coordinating of project phases, as well as the selection of engineering techniques and criteria. Strong analytical and problem solving skills are required.
•Knowledge and skill in engineering documentation procedures, development methods and project management, with the ability to rapidly master Smiths Medical ASD internal procedures and methods, such as Documentation System, ECOs, DOEs, DVTs, DRs/DAs, etc.
•Depth of knowledge of SOPs, GMP/FDA/ISO 9000, etc., principles and proven skill in integrating into engineering discipline.
•Knowledge of Statistical Process Control (SPC) and quality tools including sampling, tables and CPK; ability to design and perform required tests using appropriate tools.
•Problem solving skills to rapidly determine root cause.
•Working knowledge of six sigma tools and lean manufacturing concepts
•ASQ certification preferred.
•Excellent verbal communication skills and technical writing skills. Able to plan and conduct effective meetings and group presentations.
•Ability to coordinate and lead project team activities in an effective and efficient manner. Team members typically include diverse inter-department staff including Regulatory, Marketing, Purchasing, Design, Manufacturing Engineering, Production, Clinical, etc., requiring a significant amount of organizational and motivational skill.
•Ability to work with engineering staff members (within and outside the unit) and Operations personnel in an effective and positive manner and to provide basic on-the-job technical training to others in the department; ability to clearly convey ideas and concepts.
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Please apply online.
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