BioTalent
Job Description
The Design Quality Engineer will play a key role in New Product Introduction (NPI), leading quality system and design assurance activities to ensure alignment with FDA 21 CFR Part 820, ISO 13485, and applicable EU Medical Device Regulations for a Class III medical device environment.
Essential Duties and Responsibilities
Lead Design Assurance activities throughout the full product lifecycle
Provide expertise in Risk Management, Design Verification and Validation, Test Method Validation (TMV), Statistical Methods, Process Validation (PV), and other Design Controls
Apply structured problem-solving methods to address quality and compliance issues
Stay current on relevant regulatory requirements and industry standards
Advise and support cross-functional engineering teams
Contribute to supplier qualification efforts
Support pilot manufacturing and production setup
Perform additional duties as assigned
Minimum Qualifications
Bachelor’s degree in science or engineering
5+ years of quality experience in the medical device or life sciences sector
Experience with U.S. Class III medical devices preferred.
Skills and Abilities
Demonstrated leadership capabilities and ability to lead teams toward project goals
Strong analytical and organizational skills, with the ability to gather and interpret diverse information
Proven ability to manage priorities, set goals, and coordinate team activities
Clear and concise written and verbal communication skills across all levels of an organization
Deep understanding of quality engineering principles and medical device regulatory requirements, with the ability to train others
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Essential Duties and Responsibilities
Lead Design Assurance activities throughout the full product lifecycle
Provide expertise in Risk Management, Design Verification and Validation, Test Method Validation (TMV), Statistical Methods, Process Validation (PV), and other Design Controls
Apply structured problem-solving methods to address quality and compliance issues
Stay current on relevant regulatory requirements and industry standards
Advise and support cross-functional engineering teams
Contribute to supplier qualification efforts
Support pilot manufacturing and production setup
Perform additional duties as assigned
Minimum Qualifications
Bachelor’s degree in science or engineering
5+ years of quality experience in the medical device or life sciences sector
Experience with U.S. Class III medical devices preferred.
Skills and Abilities
Demonstrated leadership capabilities and ability to lead teams toward project goals
Strong analytical and organizational skills, with the ability to gather and interpret diverse information
Proven ability to manage priorities, set goals, and coordinate team activities
Clear and concise written and verbal communication skills across all levels of an organization
Deep understanding of quality engineering principles and medical device regulatory requirements, with the ability to train others
#J-18808-Ljbffr