US-CO-Englewood: Senior Quality Control Engineer

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Date: 09-Jun-2009

Senior Quality Control Engineer

Essential Functions:

• Provides practical guidance and direction in implementing Quality and Regulatory requirements, including: NCMR System management, ECO approval, and Process Validation oversight. • Serves as resource for the appropriate handling of quality issues within production. • Serves as a resource to functional groups within the company regarding regulatory compliance, both domestically and internationally.

Specific responsibilities may include, but are not limited to: • Provide Engineering oversight of Quality Control activities. • Provides leadership in Nonconforming Material handling. • Provide guidance and direction in the area of Quality and Regulatory. • Provides support and trending in the area of Corrective and Preventative Action. • Provides leadership, guidance and technical support to engineering, manufacturing, and to other functional groups in the areas of regulatory compliance, both domestic and international. • Use department metrics to drive continuous improvements. • Participates actively in the Quality Assurance program for suppliers. • Creates and implements company procedures. • Manages activities to assure operational quality and regulatory compliance. Requirements Knowledge, Skill and Ability:

• Knowledge of medical device quality and regulatory needs and requirements. • Ability to work at a desk, in an office area, and in a light manufacturing area. • Knowledge of computer tools such as Microsoft products. • Excellent understanding of FDA QSR requirements. • Good understanding of European community requirements. • Ability to work in a positive team environment. • Ability to communicate effectively both verbally and in writing. • Excellent leadership skills.

Education or Formal Training:

• Bachelor’s Degree in Engineering or related field required. • Master's Degree (ME, EE) or equivalent preferred.

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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/