Ops Quality Engineer II
November 9, 2012
Mgr Plant Quality
HR DEPT. APPROVAL:
For Compensation Use Only
SUMMARY OF POSITION :
Provide support to manufacturing area, helping to ensure delivery of highest quality product to the customer. Perform a wide variety of complex duties under direction to maintain company quality standards at Covidien.
ESSENTIAL FUNCTIONS :
Ensure compliance to the quality system in all activities including QSR and ISO requirements. Specify, develop and implement quality control testing procedures and methods. Applications of Process Excellence tools to solve process / product related problems. Support product transfers process and/or equipment/computerized system acquisitions. Sampling Plan and testing standards reviews. Support of Internal and External Audits. Participate in quality investigations to assess conformance to specifications, company procedures and overall compliance to regulations. Support and promote the safety and industrial hygiene objectives of the plant. Analyze, test and implement Statistical Process Controls Techniques on the manufacturing process to achieve higher standards of quality and cost reduction. Support product/process investigations performed by Manufacturing Engineers or supervisors.
Improve line processes and inspection techniques to improve quality of product.
Responsible for qualification review and/or execution, investigations related to quality, root cause analysis and product defect trending.
Support customer complaints investigations.
Analyze quality costs and implement cost savings programs .
Provide support to Quality Supplier Spec II and Manufacturing Engineersto resolve quality problems on parts or assemblies.
Provide support to all quality functions within the plant manufacturing operations.
Support or perform product/process risk assessment.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS :
Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS :
Education required/ preferred:
Bachelor of Science in Engineering
3 years or more
Knowledge of GMP’s & applicable ISO Exposure to FMEA, SPC & TQM Relevant Quality Engineering experience in an FDA or equivalent regulated environment Project management skills Demonstrated ability to effectively prioritize and accomplish work with minimal supervision Strong knowledge in CAPA system, investigations, Quality Tools, Six Sigma, Continuous Improvement and Problem Solving Skills Process and equipment qualification experience in an FDA regulated environment Process Engineering or Manufacturing Engineering experience preferable Experience in Medical Device highly desirable
Decision Quality (C) Presentation Skills Problem Solving (C) Priority Setting (C) Self-Development
ORGANIZATIONAL RELATIONSHIPS/SCOPE :
Interacts with Manufacturing, Engineering and materials departments.
50% of the time works standing and 50% office environment
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.