It takes more than great products to make a global company successful. We work hard to attract and retain people talent by creating an environment that brings out the best in every individual and by creating a culture that focuses on results and execution to ensure customer satisfaction and quality products. You are our most valuable asset by far. This is why we believe in ensuring that not only are you supported to excel in your performance and chosen career, but that we create a job environment which encourages excellence, celebrates diversity, and promotes respect. Come join our diversified team of 300+ global employees whose passion and dedication is reflected in our average tenure of 10 years of company service.
We are changing the world in Industrial, Clean Technology, Medical and Utility global markets. Come grow and change the world with us, as we capitalize on synergies in research and development, manufacturing, and marketing and sales to accelerate our business growth opportunities.
Quality Assurance Engineer
The QA Engineer is responsible for planning, directing, and performing activities that ensure compliance to all regulatory requirements. The individual will also identify opportunities to continuously improve products, service, processes, and the quality system and will work to establish a quality control program from the ground up.
Responsibilities:
• Responsible for Quality System Maintenance
• Maintain company compliance with FDA Quality System Regulations
• ISO 13485 and ISO 9001 standards
• Direct support for FDA and ISO inspections and registration
• Conduct internal and in-process audits. Initiate and support investigations pertaining to observations made during audits and ensure that deviations are addressed in a timely manner and that corrective actions meet company and regulatory requirements
• Manage suppliers' performance, approval and qualification of new / revised items which includes inspection method and validation
• Manage supplier corrective and preventive actions
• Responsible for continual product/process improvement activities to enhance the quality system. Effectively apply techniques like SPC, FMEA and DOE to drive product / process improvements
• Perform, coordinate, and participate in root cause analysis and corrective action determination to provide resolution to customer complaints,
• non-conforming material disposition and process variation
• Define control points, inspection methods, and intervals within the manufacturing processes and implement them through the use of detailed Quality Inspection Plans and Test Requirements
• All other duties as assigned
• Self starter, who is willing to establish top quality program from the ground up.
Qualifications:
• Experience in root cause analysis, process control plans, capability studies, Failure Modes and Effects Analysis and Corrective Action reporting.
• Familiarity with ISO 13485, ISO 9001 and FDA Quality System Regulations.
• Excellent analytical, prioritization, multi-tasking and communication
• Experience with accelerating life test, reliability test, confidence failure rate and MTBF is a plus
• Experience with working with offshore manufacturing a plus.
Education / Experience:
• BS engineering or equivalent experience
• 8-10 years of quality management experience
• Six Sigma, Green Belt, Black Belt, Lean certification a plus.
LumaSense offers a generous benefits package including medical, dental, vision, group life/STD/LTD, Flexible Spending Accounts, and a 401(k) Savings Plan. LumaSense is an Equal Employment Opportunity Employer and is committed to creating an environment which welcomes diverse people, opinions and ideas. If you are interested in applying for a position at LumaSense, please send your resume to HR@lumasenseinc.com
------------------------------------
********************************************************************
Read the new KIT List blog at www.kitlist.wordpress.com for job tips and to connect to our community!
Please go to www.KITlist.org to join, post jobs, or get answers to common questions. If you have any comments or questions, you can reach us directly at KITtechmoderator@KITlist.org.
By using the KIT List you agree to comply with the Terms of Use on the site, and will not use discriminatory employment practices. The KIT List is a service of Connelly Communications, Inc.
TO UNSUBSCRIBE:
Replying to KIT emails with an "unsubscribe" request does not work.
Instead, just send an email (from the same account you used to subscribe) to KITlist-Tech-unsubscribe@yahoogroups.com. If you are still receiving emails after a few days, please email us at KITtechmoderator@KITlist.org and we will manually remove you. Thanks!
Yahoo! Groups Links
<*> To visit your group on the web, go to:
http://groups.yahoo.com/group/KITlist-Tech/
<*> Your email settings:
Individual Email | Traditional
<*> To change settings online go to:
http://groups.yahoo.com/group/KITlist-Tech/join
(Yahoo! ID required)
<*> To change settings via email:
KITlist-Tech-digest@yahoogroups.com
KITlist-Tech-fullfeatured@yahoogroups.com
<*> To unsubscribe from this group, send an email to:
KITlist-Tech-unsubscribe@yahoogroups.com
<*> Your use of Yahoo! Groups is subject to:
http://docs.yahoo.com/info/terms/
No comments:
Post a Comment