Title: Quality Engineer for Process Validation
Location: Murray, UT.
Duration: 12 months.
Phone and Skype.
Looking for a Quality Engineering contractor to work on the Process Validation Remediation team. The work experience will be 100% on site at our facility in Murray, UT. They will be part of a cross-functional team made up of both contractors and employees tasked with comprehensive remediation of production processes. The work is fast paced and engaging, and a positive collaborative attitude will be rewarded by a challenging but fun work experience.
Qualifications
- 5-10 years' experience in a Quality Engineering role with a medical device manufacturer.
- Knowledge and experience supporting Process Validation in authoring and reviewing protocols and reports for IQ, OQ, PQ, and TMV activities.
- Experience with Class II and/or Class III medical devices that require sterilization and sterile barriers.
- Experience with low to mid volume production processes including light assembly, bonding, leak testing, and packaging.
- Experience with production equipment including leak testers, UV bonding, package sealing, and pad printing.
- Knowledge and experience in applying risk based statistical techniques to generate validation sampling plans.
- General knowledge and experience in applying GDP and GMP to work product.
- Ability to work collaboratively with others in a dynamic team environment
- Ability to work semi-autonomously on project tasks.
- Ability to apply creative problem solving to complex problems.
- Excellent written and oral communication skills.
- Experience in plastic injection molding process validation a plus.
- Experience in remediation and retrospective process validation a plus.
Thanks & Regards,
Bharath Vangari,
Saturn Infotech Inc,
P : 1-267-841-7988,
bvangari@saturninfotech.com
http://www.saturninfotech.com
