How are you doing? My name is Sebastian. I work with a company, world leader
in medical technology providing lifelong solutions for people with chronic
disease. I came across your contact information while I was searching for
someone specialized in Quality Assurance in the medical field. Perhaps you
could help me. I have 3 positions with my firm. I am looking for someone with
FDA and ISO experience. I am enclosing below the job description.
The company is located in Santa Rosa. 45min North of San Francisco. The
company will pay for the relocation, in addition to offer many benefits. I
would be very interested in talking with you or some of your friends. Please
feel free to send the job description to anyone who would be interested.
Thank you very much in advance. I am looking forward to talking with you.
408.748.8000 ext: 223
Sr. Quality Engineer
Provide Quality Engineering support for design and development of new products
and processes through design review, successful filing, manufacturing, and
commercialization. Also help with optimization of the existing processes and
MAJOR DUTIES AND RESPONSIBILITIES
· Provide leadership to the product development team(s) for development of
robust designs/processes through use of such methods as design challenge
testing, statistical tolerance stack-up, risk analyses, and formulation and
support of validation/quality plans.
· Ensure adequate Quality Engineering support to product development team(s)
by evaluating resources and leading a team of engineers and statisticians.
· Promote process improvement (for example, through analyzing data, leading
FMECA reviews, and application of designed experiments) in order to drive toward
process control and implementation of SPC/SQC.
· Interview, hire, and establish training plans for direct reports.
· Review performance of direct reports and provide coaching with
consideration toward established goals, department performance / metrics, and
divisional performance / metrics.
· Help drive improvement in the Coronary Quality Metrics. These should
include such measures as product development cycle time, customer complaints and
· Assist the Quality Systems group in implementing improvements to and
compliance with the quality system, especially as it relates to product
· Develop a thorough knowledge of all equipment and facilities used in
· Develop an understanding of the product, including terminology associated
with the product use and failure modes typically experienced by the customer.
· Attend product development team design control meetings and design reviews.
· Provide Pre-Production group results for Quarterly Management Review
· Work with the Regulatory Affairs department to assist in data reporting for
· Ensure adequate support of document changes and turnaround for project
· Lead group that provides leadership of risk analysis and validation project
· Other duties as defined.
· Strong leadership skills are required.
· Excellent communication skills are required.
· Minimum of five (5) years of experience in Quality Engineering and/or R&D
(at least 3 years must be in Quality Engineering) in a medical device
development and manufacturing environment.
· Minimum of a B.S. degree in a technical discipline.
· ASQ Certification in Quality and/or Reliability Engineering is preferred.
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