Bd
Medical Technology
QualityEngineerII
“Quality Engineer II at Bd. Skills: Risk assessment, Test method validation, Design validation, Process validation. Lead development of risk assessments. Lead development of test methods”
Industry & Context.
Problem solving ability; Root Cause Analysis
What They're Looking For.
Must Have
Bachelor degree in STEM, minimum of two (2) years of engineering experience, Master’s degree in STEM, engineering experience within the medical device, Solid understanding in some of the related business technologies, Sophisticated statistical and risk assessment techniques, Confirmed understanding of test method, equipment qualifications, process and design validation, risk assessment techniques, component qualification methodologies, Ability to make and present risk based decisions, Ability to analyze and optimize manufacturing and quality systems, Ability to create and provide training, Ability to create, review and coordinate test protocols and reports, Ability to generate engineering proposals, Ability to Lead multi-functional teams, Understanding of regulatory requirements, Ability to lead creation of risk management files, Ability to translate Voice of the Customer to Design Requirements, Ability to translate Design Requirements to Manufacturing control plans, Solid understanding of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO
Nice to Have
Quality Engineering Certification (ASQ) or equivalent
What You'll Do.
Lead development of risk assessments
Lead development of test methods
Support component qualifications
Support design validation
Support design verification
Support process validation
Lead basic level product investigations
Make and present risked based decisions
Assess product changes against product design
Support translation of design inputs into manufacturing control
Provide Quality Engineering representation on Product Development Teams
Participate and provide guidance to training
Participate in project planning
Participate in budgeting
Participate in scheduling
Participate in tracking
Support internal supplier audits
Support external supplier audits
Develop procedures to align with corporate standards
Develop procedures to align with industry standards
Implement procedures to align with corporate standards
Implement procedures to align with industry standards
Provide support to the regulatory department
Provide positive example
Actively promote compliance to division standards
Actively promote compliance to corporate standards
Actively promote compliance to industry standards
Maintain professional working relationship with internal customer
Maintain professional working relationship with external customer
Maintain professional working relationship with support staff
Prepare project updates
Present project updates
Prepare technical discussions
Present technical discussions
Support "Voice of the Customer" identification
Support translation into design inputs
Apply Quality Engineering tools
Support regulatory requirements
How You'll Work.
Team & Collaboration
Product Development Teams; multi-functional teams
Communication Scope
Oral presentation; Written presentation; Technical discussions
Process & Methodology
project planning, budgeting, scheduling, tracking
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