US: Staff Quality Engineer
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please visit http://sqa.fyicenter.com
Staff Quality Engineer
Perform new product process evaluations, including process capability studies, to identify areas for improvement and to reduce variability and lower total quality costs. Recommend solutions to identified problems. Implement approved changes using sound quality engineering principles and fully document requirements on a timely basis.
Support IQ, OQ, PQ (installation, operational, and process qualification) – Not including software validation. Write test protocols and implement process validation procedures in accordance with relevant standards and regulations.
Support real-time packaging validation testing of new products
Assist Regulatory Affairs and Engineering personnel in new product/process design to assure effective control procedures are established. Participate actively in product and process start-ups.
Support internal audits to assess compliance to standards and to the internal QMS
Manage NSP, DC, DHF logs and files in Box
Manage International files
Support the SI-BONE QMS
Other duties as assigned
Bachelor’s degree in engineering or technical science
8+ years of directly relevant experience with a minimum of 6 years of recent experience in FDA/cGMP or other regulated environment(s)
ASQ CQE certification preferred
Substantial knowledge of industry standards (FDA QSRs, ISO, MEDDEV, etc.).
Experienced in QMS requirements and able to provide guidance on industry practices. This includes design control, production & process controls, supplier controls, corrective and preventive action, management review, and non-conforming material controls.
Demonstrated ability to drive and deliver innovative, effective, and timely solutions. Ability to mentor others in best practices and industry standards.
Demonstrated ability to acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements
Strong knowledge of statistical quality tools with process capability and statistical quality control methodologies; demonstrated ability to determine sampling plans based on confidence and reliability
Excellent verbal and written communication skills
Must be a team player
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Team SQAFYI - Software QA Resource FYI