Quality Assurance Engineer

Stellar Consulting Solutions,
Tempe, AZ
4 hours ago

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Quality Assurance

Contract Corp-To-Corp, Contract Independent, Contract W2, 6 months

$Based on experience

Job Description

Stellar Consulting Solutions is a boutique business & technology consulting company headquartered in Atlanta, GA. We deliver high quality, agile, and experienced workforce for niche technology projects of any scale. We help forward thinking clients to solve specific problems by understanding their needs and align talent that can move fluidly
to match skill supply and demand on a real-time basis.

Stellar Consulting has a unique combination of technical and digital skills to recruit, engage, and retain qualified talent. We have a stellar reputation for striving to achieve high ethical standards. Our use of Innovative techniques and industry best practices has made us one of the fastest growing boutique firms delivering to enterprise business.

Job Description: Quality Assurance Engineer
EU-MDR submissions lead to quality activities surrounding EU-MDR submission of products. Works with cross-functional teams to remediate gaps related to EU-MDR requirements and meets all deliverables in line with division and business goals.

Project Management: Assists with creating strategic plans and budgets for EU-MDR. Coordinates with team members, internal and external suppliers, and outside professionals to ensure project output meets business needs as well as applicable regulatory requirements.

Design to Manufacturing Transfer: supports product updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing.

Test Method Development & Validation leads the development and validation of clinically relevant test methods that adequately challenge product design and processes.

Testing: Leads verification and validation activities for products and processes in support of EU-MDR requirements.

Other responsibilities may include, but are not limited to:
-Support/lead design and process root cause analysis and support non-conforming product and complaint investigations.
-Prepare and present project updates and technical discussions.
-Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)
-Leads development of risk assessments and test methods.
-Leads component qualifications, design validation / verification and process validation.
-Leads product investigations.
-Assess product changes against product design.
-Supports translation of design inputs into manufacturing control plans.
-Prepare and present project updates and technical discussions.
-Provide support to the regulatory department in writing technical submissions.
-Complies with company procedures and policies, government regulations.
-Other duties and projects, as assigned.

Required Qualifications:
-Knows how products are used and impact the user(s) so that risk can be managed effectively
-Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
-Ability to lead creation of risk management files.
-Ability to develop solutions with business impact.
-Advanced statistical and risk assessment techniques
-Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
-Ability to make and present risk-based decisions
-Ability to analyze and optimize manufacturing and quality systems
Product, design & prototyping
-Ability to create and provide training
-Ability to create, review and coordinate test protocols and reports.
-Ability to generate engineering proposals.
-Understanding of regulatory requirements including ISO 13485, ISO 14971

Preferred Qualifications:
Quality Engineering Certification (ASQ) or equivalent

Education and/or Experience:
BS in Engineering