US-MN-Minneapolis: Quality Engineer
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please visit http://sqa.fyicenter.com
• Assists in the review and approval process to assure medical software is developed, verified, validated and documented in accordance with regulatory requirements.
• Serve as a Quality representative on product development and sustaining engineering project teams.
• Assures all actions required to optimize the quality, manage the risk, and maintain the compliance of our products are planned and completed, and that the results drive quality and quality system actions.
• Leads continual optimization of quality system processes and documentation.
• Oversees the execution of one or more quality system processes; e.g. – supplier quality, CAPA, training, design controls, internal auditing, etc.
• Provides support for acceptance, packaging, shipping and exporting activities.
• Provides support for and participates as a subject matter expert in regulatory audits.
• Develops and conducts Quality System training programs.
• Leads the implementation of electronic management systems; e.g. – document control, CAPA, training, audit, etc.
• Analyze and solve quality related problems with products and processes.
• At least 5 years experience quality engineering. Two years experience in medical devices.
• Bachelors Degree in Engineering required. Software Engineering degree preferred.
• Must have strong working knowledge of U.S. FDA medical device laws and regulations and Quality System Regulation (QSR).
• Must have strong working knowledge of ISO 13485 or ISO 9001 international standards for quality management systems.
• Working knowledge of the MDD/CMDR and other international medical device regulations is required.
• Experience with Design Assurance product development activities required. Experience with software medical devices is highly preferred.
• Certification in QAE, Auditing, or Six Sigma is desired.
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Team SQAFYI - Software QA Resource FYI