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Job Summary:

The Sr. Quality Engineer develops, establishes, and maintains Quality Engineering methodologies, systems and practices that meet quality and customer requirements. The Sr. QE drives quality improvements focused on New Product Introductions, Product Transfers and Marketed Product Support. This position will provide sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Supports quality improvement, disciplines, decisions, and practices. The Sr. Quality Engineer will manage and/or provide guidance to product sterilization, product testing, control environment/cleanroom testing, and actively participate in document changes, Corrective and Preventive Actions (CAPAs) and Complaints and Nonconforming Material Review process.

Duties:

Follow all regulations, standards, procedures, and work instructions defined in the Quality System Manual
Sound knowledge of inspection principles and techniques
Sound knowledge of validation principles
Ability to interpret Quality Standards for implementation
Manage and/or provide guidance to product sterilization, product testing and control environment/cleanroom testing.
Analytical Problem Solving- ability to identify problems, define problem statements clearly and accurately, apply structured and disciplined methodology to identify data-driven root causes
Manage and/or investigate and document CAPAs
Update or create procedures, work instructions, forms and labels using Word, Excel, Label View, etc.
Review and release sterile product
Review document changes as assigned
Support the compilation of technical and design history files
Participate in external, internal, supplier and design history file audits, as needed
Assign and review deviations.
Support inspections and audits performed by Customers, FDA, Notified Body, OSHA
May perform direct supervision of Quality Assurance staff
Perform other duties as assigned by supervisor or manager

Education:

Bachelor's Degree required in a Technical or Scientific discipline
Minimum 8 years of experience in a medical device design and manufacturing environment
Ability to apply learned technology to products and processes
Software proficiency: Microsoft Word, Microsoft Excel, Adobe Acrobat, LabelView
Strong background in

FDA 21 CFR

Regulations, ISO 13485, Health Canada Regulations, European Medical Device Regulations, ISO 14971

Possess excellent verbal and written communication skills in English. Ability to read, write and speak English in order to comprehend and execute internal Procedures, Drawings, Manufacturing Work Instructions (MWI), etc.
Attention to details and excellent organization skills

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Find & Apply For Validation Engineer Jobs in Eagan, Minnesota

Sr. Quality Engineer