[Outsource:54850] US-MN-Minneapolis: Quality Engineer

US-MN-Minneapolis: Quality Engineer
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99667313_Quality_Engineer.html
To see other opportunities, please visit http://sqa.fyicenter.com
Date: 23-Aug-2011

Quality Engineer

• 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.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com

--
Introduce business in 3800 cities. How?
=====================================================
Thanks for using group.
Moderator

1) This group is managed by www.BRCIndex.blogspot.com
2) Post your message with your linkedin Profile (Visit linkedin.com) to confirm your identity and refer business.
3) Visit www.BRCIndex.blogspot.com (3800 Business Referral Club)
4) Reply to two message before posting new one.
5) Donot post same message in all 3800 business Referral Club.

You received this message because you are subscribed to the Google Groups "Outsource" group.
To post to this group, send email to Outsource@googlegroups.com
To unsubscribe from this group, send email to Outsource-unsubscribe@googlegroups.com
For more options, visit this group at http://groups.google.com/group/Outsource