Quality Design Assurance Engineer

Senior QE would be responsible for providing new products and solutions quality assurance support

. This position reports to the Manager of Quality Engineering
. Provide expert design assurance guidance and support for product, program, and solution development projects.
. Quality by Design
. Design control
. Product and process validation
. cGMP
. Risk management
. Interface and coordinate programs in order to best achieve organizational goals.
. Lead and support continuous improvement activities.

Requirements:

. 7+ years progressive, seasoned design assurance engineering in pharmaceutical or biotech industries
. Extensive validation experience within the pharmaceutical or biotech industries
. BS degree
. Familiarity with quality by design, QbD
. Hands on experience in the application of quality system standards
. Sterile processing
. Contamination control
. Quality control and testing
. Failure analysis and problem solving
. Continuous improvement
. Project leadership
. Certified Quality Engineer
. Six Sigma Certification
. Applied/industrial statistics

Location Burlington / Chelmsford MA; relocation possible

Compensation negotiable

Contact: Leslie Gabriele
Gabriele & Company
Recruiters for Manufacturing and Materials
781-276-7999