To apply for this position, please visit this Website.
http://biotech.fyicenter.com/jobs/99893450_Senior_Quality_Control_Engineer.html
To see other BioTech job opportunities, please visit http://biotech.fyicenter.com/
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.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
