Job #: 10021902 – P
TriStaff is partnering with a successful medical company that is growing globally and acquiring complimentary product lines. To ensure a seamless bridge between these product lines, they are adding a Principal Quality Engineer to focus on process, including rules, FDA and ISO 9001 regulations related to the project, and assessing the quality of documentation. As an enterprise product, full attention will be paid to quality issues in the software development process down to proper testing to the product release.
Their enterprise product includes unique safety features, data security, improved real time embedded controls, data tracking, Windows applications software, networking through TCP/IP, and wireless PDA capability with 802.11. My clients business focus is providing complete solutions that integrate seamlessly into hospital systems to provide 100% reliability. Proven executive leadership and great customer response have also attracted increased sales. Their corporate culture emphasizes close harmony between Software R&D, QA Testing, Systems Engineering, and Marketing through a commitment to iterative, agile development.
In this key role, you will be responsible for:
Creating basic rules and documenting the process flow from R&D software design, QA testing, to customer release (ESO).
Interacting with Marketing, software R&D, and Systems Engineering to make sure that documentation and testing are done and checked before product release.
Auditing your self for design control and risk analysis.
Applying risk management principles and quality engineering concepts and test methods during the product lifecycle.
Executing the process for Product/Service Safety Risk Management throughout the product life cycle.
Generating practical, sustainable, and creative options to solve problems and create business opportunities, while maximizing available resources.
Ensuring adherence to FDA and ISO 9001 regulations during the entire process down to product release.
Selecting appropriate test methods, including test protocols and statistical methods.
Ensuring that quality objectives and goals have been identified and defined, including specifications, procedures, and testing.
Ensuring that all documentation is properly kept to support DHF
Applying risk management principles for risk assessment, change order, and product safety.
This position would appeal to someone who wants to apply their quality process background to a brand new enterprise initiative from engineering development to product release.
Your challenge will be to adopt to an extremely fast-paced process and hit the ground running with 5 projects at different phases of development due to utilization of the agile development process.
If this position speaks to you, please send your resume in Word format to Amy Moser (amy@tristaff.com).
***PLEASE SEND RESUME AS A WORD ATTACHMENT!***
JOB REQUIREMENTS:
Must have senior experience with risk management principles for a complex FDA-approved product, including both new and changes to those products from design changes to manufacturing.
Must have strong knowledge of FDA, Quality Management Process, and Good Documentation Practices.
Must have experience with other processes that govern regulated environments, such as ISO14971, ISO9001, ISO13485, QSR, EN26001, Six Sigma, etc.
Plusses would be ASQ certification and working knowledge of DFSS.
Ability to communicate with systems engineering, software engineering, testers, and marketing.
Must have BS degree in Electrical, Mechanical, or Computer Science or related fields.
*** FOR OTHER OPPORTUNITIES AND TO REGISTER WITH TRISTAFF, PLEASE VISIT OUR WEBSITE AT www.tristaff.com***
KEY WORDS: Quality Engineering, medical device, FDA, SOPs, best practices, V&V, Windows2003/2005, SQL Server, TCP/IP, Virtualization, VMWare, ASQ, CQA, CQE, CMQ/OE, LSS, IQ-OQ-PQ, HIPAA, GMP, ISO, software, hardware, manufacturing, SQL, client/server, Microsoft SQL Server database, RTOS, Firmware, Embedded, enterprise, DHF, Risk Management, Risk Analysis, Process Failure Mode, Hazard Analysis, Design History File (DHF), Six Sigma, DMAIC, EN46001, DFSS. ASQ. ESO.